FDA Guidance Documents

Currently effective CDRH Final guidance (Guidance Document and Special Controls). Draft, CPG, Memorandum, and Small Entity Compliance Guides are excluded.

Total 434 documents, 387 with extracted full text. Newest first within each category. Catalog pages without full text link to the official FDA source.

Categories

• Digital Health & Cybersecurity (23)
• Premarket (510(k) / PMA / De Novo / IDE) (290)
• Quality / QMSR / Manufacturing (7)
• IVD / Companion Diagnostics (7)
• Labeling / UDI (14)
• Postmarket / Recalls / Vigilance (25)
• Radiation / Imaging (44)
• Clinical / Real-World Evidence (3)
• General / Other (21)

Digital Health & Cybersecurity

23 documents, 23 with full text.

• Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff (2026-02-03)
• Computer Software Assurance for Production and Quality Management System Software: Guidance for Industry and Food and Drug Administration Staff (2026-02-03)
• Clinical Decision Support Software: Guidance for Industry and Food and Drug Administration Staff (2026-01-29)
• General Wellness: Policy for Low Risk Devices: Guidance for Industry and Food and Drug Administration Staff (2026-01-06)
• Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions: Guidance for Industry and Food and Drug Administration Staff (2025-08-18)
• Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff (2023-11-17)
• Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology: Guidance for Industry and Food and Drug Administration Staff (2023-09-29)
• Off-The-Shelf Software Use in Medical Devices: Guidance for Industry and Food and Drug Administration Staff (2023-08-11)
• Qualification of Medical Device Development Tools: Guidance for Industry, Tool Developers, and Food and Drug Administration Staff (2023-07-17)
• Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff (2023-06-14)
• Policy for Device Software Functions and Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff (2022-09-28)
• Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices: Guidance for Industry and Food and Drug Administration Staff (2022-09-28)
• Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions: Guidance for Industry and Food and Drug Administration Staff (2022-09-28)
• Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions: Guidance for Industry and FDA Staff (2022-09-28)
• Multiple Function Device Products: Policy and Considerations: Guidance for Industry and Food and Drug Administration (2020-07-29)
• Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act: Guidance for Industry and Food and Drug Administration Staff (2019-09-27)
• Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests : Guidance for Industry and Food and Drug Administration Staff (2018-06-15)
• Medical Device Accessories - Describing Accessories and Classification Pathways: Guidance for Industry and FDA Staff (2017-12-20)
• Deciding When to Submit a 510(k) for a Software Change to an Existing Device: Guidance for Industry and Food and Drug Administration Staff (2017-10-25)
• Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices: Guidance for Industry and Food and Drug Administration Staff (2017-09-06)
• Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff (2016-12-28)
• Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff (2013-08-14)
• General Principles of Software Validation: Guidance for Industry and FDA Staff (2002-01-11)

Premarket (510(k) / PMA / De Novo / IDE)

290 documents, 271 with full text.

• Dental Curing Lights - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff (2026-09-02)
• Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff (2026-09-02)
• Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff (2026-08-03)
• Hemodialysis Blood Tubing Sets - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff (2026-07-23)
• Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements: Guidance for Industry and Food and Drug Administration Staff (2026-06-05)
• Content of Human Factors Information in Medical Device Marketing Submissions: Guidance for Industry and Food and Drug Administration Staff (2026-05-29)
• Patient-Matched Guides for Orthopedic Implants: Guidance for Industry and Food and Drug Administration Staff (2026-05-07)
• Medical Devices with Indications Associated with Weight Loss - Premarket Considerations: Guidance for Industry and Food and Drug Administration Staff (2026-03-13)
• Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food and Drug Administration Staff (2025-12-18)
• eCopy Program for Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff (2025-12-03)
• Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff (2025-08-22)
• Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program: - Final Guidance for Industry and Food and Drug Administration Staff (2025-05-29)
• Evaluation of Sex-Specific Data in Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff (2025-03-31)
• Premarket Approval Application and Humanitarian Device Exemption Modular Review: Guidance for Industry and FDA Staff (2025-01-13)
• Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices: Guidance for Industry and Food and Drug Administration Staff (2024-11-26)
• Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff (2024-11-22)
• Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff (2024-11-22)
• 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review: Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations (2024-11-21)
• Endosseous Dental Implants and Endosseous Dental Implant Abutments - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff (2024-10-15)
• Dental Impression Materials - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff (2024-09-30)
• Dental Ceramics - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff (2024-09-30)
• Dental Cements - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff (2024-09-30)
• Air Powered Dental Handpieces and Air Motors - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff (2024-09-30)
• FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff (2024-08-23)
• Electronic Submission Template for Medical Device De Novo Requests: Guidance for Industry and Food and Drug Administration Staff (2024-08-23)
• Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff (2024-01-08)
• Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions: Guidance for Industry and Food and Drug Administration Staff (2023-11-02)
• Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring: Guidance for Industry and Food and Drug Administration Staff (2023-10-19)
• Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment: Guidance for Industry and Food and Drug Administration Staff (2023-10-10)
• Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff (2023-10-10)
• Electronic Submission Template for Medical Device 510(k) Submissions: Guidance for Industry and Food and Drug Administration Staff (2023-10-02)
• Breakthrough Devices Program: Guidance for Industry and Food and Drug Administration Staff (2023-09-14)
• Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : Guidance for Industry and Food and Drug Administration Staff (2023-09-08)
• Enforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease (COVID-19) Public Health Emergency : Guidance for Industry and Food and Drug Administration Staff (2023-09-05)
• Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff (2023-07-27)
• Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures: Guidance for Industry and Food and Drug Administration Staff (2023-05-26)
• Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff (2023-04-14)
• Soft (Hydrophilic) Daily Wear Contact Lenses - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff (2023-03-28)
• General Considerations for Animal Studies Intended to Evaluate Medical Devices: Guidance for Industry and Food and Drug Administration Staff (2023-03-28)
• Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff (2023-03-27)
• Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19): Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff (2023-03-27)
• Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices: Guidance for Industry and Food and Drug Administration Staff (2023-02-21)
• Medical X-Ray Imaging Devices Conformance with IEC Standards: Guidance for Industry and Food and Drug Administration Staff (2023-02-21)
• Marketing Clearance of Diagnostic Ultrasound Systems and Transducers : Guidance for Industry and Food and Drug Administration Staff (2023-02-21)
• Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (Revised): Guidance for Test Developers and Food and Drug Administration Staff (2023-01-12)
• Policy for Coronavirus Disease-2019 Tests (Revised): Guidance for Developers and Food and Drug Administration Staff (2023-01-12)
• Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions: Guidance for Industry and Food and Drug Administration Staff (2022-10-26)
• Procedures for Handling Post-Approval Studies Imposed by PMA Order: Guidance for Industry and Food and Drug Administration Staff (2022-10-07)
• User Fees for 513(g) Requests for Information: Guidance for Industry and Food and Drug Administration Staff (2022-10-05)
• User Fees and Refunds for Premarket Notification Submissions (510(k)s): Guidance for Industry and Food and Drug Administration Staff (2022-10-05)
• User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications: Guidance for Industry and Food and Drug Administration Staff (2022-10-05)
• User Fees and Refunds for De Novo Classification Requests : Guidance for Industry and Food and Drug Administration Staff (2022-10-05)
• FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration Staff (2022-10-03)
• FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration Staff (2022-10-03)
• FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration Staff (2022-10-03)
• Display Devices for Diagnostic Radiology: Guidance for Industry and Food and Drug Administration Staff (2022-09-28)
• Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products: Guidance for Industry and Food and Drug Administration Staff (2022-08-17)
• Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff (2022-06-16)
• Electromagnetic Compatibility (EMC) of Medical Devices: Guidance for Industry and Food and Drug Administration Staff (2022-06-06)
• Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus: Guidance for Industry and Food and Drug Administration Staff (2022-05-06)
• Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food and Drug Administration Staff (2022-04-21)
• Facet Screw Systems - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff (2022-04-13)
• Denture Base Resins - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff (2022-04-13)
• Surgical Sutures - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff (2022-04-11)
• Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff (2022-04-11)
• Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation: Guidance for Industry and Food and Drug Administration Staff, And Other Stakeholders (2022-01-26)
• Patient Engagement in the Design and Conduct of Medical Device Clinical Studies: Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders (2022-01-26)
• Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH): Guidance for Industry and Food and Drug Administration Staff (2021-12-27)
• Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff (2021-12-23)
• De Novo Classification Process (Evaluation of Automatic Class III Designation): Guidance for Industry and Food and Drug Administration Staff (2021-10-05)
• Acceptance Review for De Novo Classification Requests: Guidance for Industry and Food and Drug Administration Staff (2021-10-05)
• Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol: Guidance for Industry and Food and Drug Administration Staff (2021-07-09)
• Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions: Guidance for Industry and Food and Drug Administration Staff (2021-05-20)
• Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations: Guidance for Industry and Food and Drug Administration Staff (2021-05-20)
• Safer Technologies Program for Medical Devices: Guidance for Industry and Food and Drug Administration Staff (2021-01-06)
• Mouse Embryo Assay for Assisted Reproduction Technology Devices (2021-01-05)
• Product Labeling for Laparoscopic Power Morcellators: Guidance for Industry and Food and Drug Administration Staff (2020-12-30)
• Spinal Plating Systems - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff (2020-12-11)
• Magnetic Resonance (MR) Receive-only Coil - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff (2020-12-11)
• Regulatory Considerations for Microneedling Products: Guidance for Industry and Food and Drug Administration Staff (2020-11-10)
• Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use: Guidance for Industry and Food and Drug Administration Staff (2020-09-29)
• Saline, Silicone Gel, and Alternative Breast Implants: Guidance for Industry and FDA Staff (2020-09-29)
• Breast Implants - Certain Labeling Recommendations to Improve Patient Communication: Guidance for Industry and Food and Drug Administration Staff (2020-09-29)
• Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use: Guidance for Industry and Food and Drug Administration Staff (2020-09-29)
• The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff (2020-09-25)
• Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff (2020-09-25)
• Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff (2020-09-25)
• Cutaneous Electrodes for Recording Purposes - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff (2020-08-14)
• Conventional Foley Catheters - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff (2020-08-14)
• Clinical Investigations for Prostate Tissue Ablation Devices: Guidance for Industry and Food and Drug Administration Staff (2020-07-15)
• Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A: Guidance for Industry and Food and Drug Administration Staff (2020-03-27)
• Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery: Guidance for Industry and Food and Drug Administration Staff (2020-03-09)
• Bone Anchors - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff (2020-03-03)
• Recommendations for Dual 510(k) and CLIA Waiver by Application Studies: Guidance for Industry and Food and Drug Administration Staff (2020-02-26)
• Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff (2019-12-20)
• Real-Time Premarket Approval Application (PMA) Supplements: Guidance for Industry and FDA Staff (2019-12-16)
• Annual Reports for Approved Premarket Approval Applications (PMA) : Guidance for Industry and Food and Drug Administration Staff (2019-12-16)
• Acceptance and Filing Reviews for Premarket Approval Applications (PMAs): Guidance for Industry and Food and Drug Administration Staff (2019-12-16)
• 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes: Guidance for Industry and FDA Staff (2019-12-16)
• Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling Considerations: Guidance for Industry and Food and Drug Administration Staff (2019-10-10)
• Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling: Guidance for Industry and Food and Drug Administration Staff (2019-10-10)
• Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration (2019-09-20)
• The Special 510(k) Program: Guidance for Industry and Food and Drug Administration Staff (2019-09-13)
• The Abbreviated 510(k) Program: Guidance for Industry and Food and Drug Administration Staff (2019-09-13)
• Humanitarian Device Exemption (HDE) Program: Guidance for Industry and Food and Drug Administration Staff (2019-09-06)
• Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications: Guidance for Industry and Food and Drug Administration Staff (2019-08-30)
• Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions: Guidance for Industry and Food and Drug Administration Staff (2019-08-30)
• Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff (2019-07-26)
• Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials: Guidance for Institutional Review Boards, Industry, Clinical Investigators, and Food and Drug Administration Staff (2019-07-11)
• Utilizing Animal Studies to Evaluate Organ Preservation Devices: Guidance for Industry and Food and Drug Administration Staff (2019-05-08)
• Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices: Guidance for Industry and Food and Drug Administration Staff (2019-04-26)
• Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices): Guidance for Industry and Food and Drug Administration Staff (2019-03-15)
• The Least Burdensome Provisions: Concept and Principles: Guidance for Industry and FDA Staff (2019-02-05)
• Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices: Guidance for Industry and Food and Drug Administration Staff (2019-02-01)
• Manufacturing Site Change Supplements: Content and Submission: Guidance for Industry and Food and Drug Administration Staff (2018-12-17)
• Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics: Guidance for Industry and Food and Drug Administration Staff (2018-09-25)
• Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing: Guidance for Industry and Food and Drug Administration Staff (2018-09-20)
• Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices: Guidance for Industry and Food and Drug Administration Staff (2018-09-14)
• Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics : Guidance for Stakeholders and Food and Drug Administration Staff (2018-04-13)
• Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions: Guidance for Industry and Food and Drug Administration Staff (2018-02-21)
• Technical Considerations for Additive Manufactured Medical Devices: Guidance for Industry and Food and Drug Administration Staff (2017-12-05)
• FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions: Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards, and Food and Drug Administration Staff (2017-12-05)
• Pediatric Information for X-ray Imaging Device Premarket Notifications: Guidance for Industry and Food and Drug Administration Staff (2017-11-28)
• Product Labeling for Certain Ultrasonic Surgical Aspirator Devices: Guidance for Industry and Food and Drug Administration Staff (2017-10-30)
• Deciding When to Submit a 510(k) for a Change to an Existing Device: Guidance for Industry and Food and Drug Administration Staff (2017-10-25)
• Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses: Guidance for Industry and Food and Drug Administration Staff (2017-09-15)
• Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff (2017-09-12)
• Procedures for Meetings of the Medical Devices Advisory Committee: Guidance for Industry and Food and Drug Administration Staff (2017-09-01)
• Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions: Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators and Food and Drug Administration Staff (2017-01-13)
• Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions: Guidance for Industry and Food and Drug Administration Staff (2016-12-27)
• Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes: Guidance for Industry and Food and Drug Administration Staff (2016-11-29)
• Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes: Guidance for Industry and Food and Drug Administration Staff (2016-11-07)
• Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization: Guidance for Industry and Food and Drug Administration Staff (2016-10-31)
• Reporting of Computational Modeling Studies in Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff (2016-09-21)
• Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices: Guidance for Industry and Food and Drug Administration Staff (2016-09-01)
• Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery: Guidance for Industry and Food and Drug Administration Staff (2016-08-15)
• Adaptive Designs for Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff (2016-07-27)
• Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices: Guidance for Industry and Food and Drug Administration Staff (2016-06-21)
• Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices : Guidance for Industry and Food and Drug Administration Staff (2016-04-20)
• Radiation Biodosimetry Medical Countermeasure Devices: Guidance for Industry and Food and Drug Administration Staff (2016-04-18)
• Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices: Guidance for Industry and Food and Drug Administration Staff (2016-03-22)
• Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails: Guidance for Industry and Food and Drug Administration Staff (2016-03-07)
• Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays: Guidance for Industry and Food and Drug Administration Staff (2016-02-09)
• Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices: Guidance for Industry and Food and Drug Administration Staff (2015-12-15)
• Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings: Guidance for Industry and Food and Drug Administration Staff (2015-12-09)
• Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems: Guidance for Industry and Food and Drug Administration Staff (2015-08-18)
• Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices (2015-08-17)
• Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices: Guidance for Industry and Food and Drug Administration Staff (2015-06-17)
• Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval: Guidance for Industry and Food and Drug Administration Staff (2015-04-13)
• Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling : Guidance for Industry and Food and Drug Administration Staff (2015-03-17)
• Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications: Guidance for Industry and Food and Drug Administration Staff (2015-02-11)
• Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex: Guidance for Industry and Food and Drug Administration Staff (2014-12-02)
• Infusion Pumps Total Product Life Cycle: Guidance for Industry and FDA Staff (2014-12-02)
• Design Considerations for Devices Intended for Home Use: Guidance for Industry and Food and Drug Administration Staff (2014-11-24)
• Molecular Diagnostic Instruments with Combined Functions: Guidance for Industry and Food and Drug Administration Staff (2014-11-12)
• Custom Device Exemption: Guidance for Industry and Food and Drug Administration Staff (2014-09-24)
• FDA Decisions for Investigational Device Exemption Clinical Investigations: Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff (2014-08-19)
• In Vitro Companion Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff (2014-08-06)
• The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]: Guidance for Industry and Food and Drug Administration Staff (2014-07-28)
• Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff (2014-06-19)
• Providing Information about Pediatric Uses of Medical Devices: Guidance for Industry and FDA Staff (2014-05-01)
• Types of Communication During the Review of Medical Device Submissions: Guidance for Industry and FDA Staff (2014-04-04)
• Premarket Assessment of Pediatric Medical Devices: Guidance for Industry and FDA Staff (2014-03-24)
• Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and FDA Staff (2013-11-25)
• Design Considerations for Pivotal Clinical Investigations for Medical Devices: Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA Staff (2013-11-07)
• Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies: Guidance for Industry and Food and Drug Administration Staff (2013-10-01)
• Assay Migration Studies for In Vitro Diagnostic Devices: Guidance for Industry and FDA Staff (2013-04-25)
• Medical Device Classification Product Codes - Guidance for Industry and Food and Drug Administration Staff (2013-04-10)
• Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi - Guidance for Industry and FDA Staff (2013-03-27)
• Investigational Device Exemption (IDE) Guidance for Retinal Prostheses: Guidance for Industry and FDA Staff (2013-03-06)
• Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff (2013-03-03)
• Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation - Guidance for Industry and Food and Drug Administration Staff (2013-02-14)
• The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems: Guidance for Industry and Food and Drug Administration Staff (2012-11-09)
• Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence - Guidance for Industry and FDA Staff (2011-03-07)
• Blood Lancet Labeling - Guidance for Industry and Food and Drug Administration Staff (2010-11-28)
• Contact Lens Care Products Labeling: Guidance for Industry and Food and Drug Administration Staff (2010-08-15)
• In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA Staff (2010-06-25)
• Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems - Guidance for Industry and FDA Staff (2010-04-17)
• Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials (PDF Version) (2010-02-05)
• Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process: Guidance for Industry and FDA Staff (2008-12-11)
• Clinical Study Designs for Catheter Ablation Devices for Treatment of Atrial Flutter: Guidance for Industry and FDA Staff (2008-08-05)
• Intravascular Administration Sets Premarket Notification Submissions [510(k)]: Guidance for Industry and FDA Staff (2008-07-11)
• Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis: Guidance for Industry and FDA Staff (2008-04-15)
• Preparation and Review of Investigational Device Exemption Applications (IDEs) for Total Artificial Discs: Guidance for Industry and FDA Staff (2008-04-11)
• Coronary and Carotid Embolic Protection Devices - Premarket Notification [510(k)] Submissions : Guidance for Industry and FDA Staff (2008-02-15)
• Medical Glove Guidance Manual: Guidance for Industry and FDA Staff (2008-01-22)
• Biological Indicator (BI) Premarket Notification [510(k)] Submissions : Guidance for Industry and FDA Staff (2007-10-04)
• Non-clinical Information for Femoral Stem Prostheses: Guidance for Industry and FDA Staff (2007-09-17)
• Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions: Guidance for Industry and FDA Staff (2007-09-13)
• Bundling Multiple Devices or Multiple Indications in a Single Submission: Guidance for Industry and FDA Staff (2007-06-22)
• Pre-Clinical and Clinical Studies for Neurothrombectomy Devices: Guidance for Industry and FDA Staff (2007-06-18)
• Dental Handpieces - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff (2007-05-02)
• Keratome and Replacement Keratome Blades Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff (2006-09-18)
• Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable : Guidance for Sponsors, Institutional Review Boards, and Food and Drug Administration Staff (2006-04-25)
• Tonometers - Premarket Notification [510(k)] Submissions : Guidance for Industry and FDA Staff (2006-03-27)
• Pharmacogenetic Tests and Genetic Tests for Heritable Markers: Guidance for Industry and FDA Staff (2006-02-09)
• Medical Devices with Sharps Injury Prevention Features - Guidance for Industry and FDA Staff (2005-08-08)
• Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff (2005-07-26)
• Clinical Data Presentations for Orthopedic Device Applications - Guidance for Industry and FDA Staff (2004-12-01)
• Clinical Trial Considerations: Vertebral Augmentation Devices to Treat Spinal Insufficiency Fractures - Guidance for Industry and FDA Staff (2004-10-23)
• Class II Special Controls Guidance Document: Serological Assays for the Detection of Beta-Glucan (PDF version) (2004-09-23)
• Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices: Guidance for Industry and FDA Staff (2004-06-02)
• Class II Special Controls Guidance Document: Immunomagnetic Circulating Cancer Cell Selection and Enumeration System (PDF version) (2004-05-11)
• Guidance for Industry and FDA Staff: Spinal System 510(k)s (2004-05-02)
• Surgical Masks - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff (2004-03-04)
• Guidance for Industry and FDA Staff: Vocal Fold Medialization Devices - Premarket Notification [510(k)] Submissions (2004-02-12)
• Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff (2003-12-18)
• Quality System Information for Certain Premarket Application Reviews : Guidance for Industry and FDA Staff (2003-02-03)
• Determination of Intended Use for 510(k) Devices - Guidance for CDRH Staff (Update to K98-1) (2002-12-02)
• Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery - Guidance for Industry (2002-06-17)
• Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors: Final Guidance for Industry and FDA Staff (2001-07-06)
• Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff (2001-05-28)
• Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff (2001-02-27)
• Content of Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport and Storage of Organs for Transplantation - Guidance for Industry and FDA Reviewers (2001-01-15)
• Guidance Document for Dura Substitute Devices - Guidance for Industry (2000-11-08)
• Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources - Guidance for Industry (2000-08-01)
• Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s - Guidance for Industry and FDA Reviewers/Staff (2000-07-21)
• Guidance for Premarket Submissions of Orthokeratology Rigid Gas Permeable Contact Lenses - Guidance for Industry (2000-04-09)
• Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers: Guidance for Industry (2000-03-11)
• Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer: Guidance for Industry and for FDA Reviewers (2000-01-24)
• Guidance for the Content of Premarket Notifications for Penile Rigidity Implants - Guidance for Industry and for FDA Staff (2000-01-15)
• Guidance Document for the Preparation of IDEs for Spinal Systems - Guidance for Industry and/or FDA Staff (2000-01-12)
• Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants - Guidance for Industry and FDA Reviewers (2000-01-02)
• Guidance for Cardiovascular Intravascular Filter 510(k) Submissions - Guidance for Industry and FDA Staff (1999-11-25) (catalog)
• Guidance Document for Powered Muscle Stimulator 510(k)s - Guidance for Industry, FDA Reviewers/Staff and Compliance (1999-06-08)
• Immunotoxicity Testing Guidance (1999-05-05)
• Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects: Guidance for Industry and FDA Staff (1999-03-19)
• Guidance on 510(k) Submissions for Keratoprostheses - Guidance for Industry and for FDA Reviewers/Staff (1999-03-02)
• Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh - Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance (1999-03-01)
• Guidance for Dermabrasion Devices - Guidance for Industry (1999-03-01)
• Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization To Chemicals In Natural Rubber Products - Guidance for Industry and FDA Reviewers/Staff (1999-01-12)
• Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems : Guidance for Industry (1998-12-02)
• Guidance for the Submission of Premarket Notifications For Radionuclide Dose Calibrators - Guidance for Industry (1998-11-19)
• Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance - Version 1 - Guidance for Industry (1998-11-18)
• Aqueous Shunts - 510(k) Submissions - Guidance for Industry and for FDA Reviewers/Staff (1998-11-15)
• Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement) - Guidance for Industry (1998-11-04)
• Cardiac Monitor Guidance (including Cardiotachometer and Rate Alarm) - Guidance for Industry (1998-11-04)
• General/Specific Intended Use - Guidance for Industry (1998-11-03)
• Noise Claims in Hearing Aid Labeling - Guidance for Industry (1998-10-20)
• Guidance Document For Nonprescription Sunglasses - Guidance for Industry (1998-10-08)
• Guidance Document for Powered Suction Pump 510(k)s - Guidance for Industry and FDA Reviewers/Staff (1998-09-29)
• OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits - Guidance for Industry and FDA Staff (1998-08-17)
• Revised Procedures for Adding Lens Finishing Laboratories to Approved Premarket Approval Applications for Class III Rigid Gas Permeable Contact Lenses for Extended Wear - Guidance for Industry and FDA Staff (1998-08-10)
• Latex Condoms for Men - Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions: Guidance for Industry (1998-07-23)
• Uniform Contraceptive Labeling - Guidance for Industry (1998-07-22)
• Guidance Document For Washers And Washer-Disinfectors Intended For Processing Reusable Medical Devices (1998-06-01) (catalog)
• Supplements to Approved Applications for Class III Medical Devices: Use of Published Literature, Use of Previously Submitted Materials, and Priority Review : Guidance for Industry (1998-05-19) (catalog)
• Guidance For The Content Of Premarket Notifications For Esophageal And Tracheal Prostheses - Guidance For Industry (1998-04-27)
• Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff (1998-02-18)
• Kit Certification for 510(k)s (1997-06-30) (catalog)
• Convenience Kits Interim Regulatory Guidance (1997-05-19)
• Non-Invasive Blood Pressure (NIBP) Monitor Guidance (1997-03-09) (catalog)
• Reviewers Guidance Checklist For Orthopedic External Fixation Devices Version #5 (1997-02-20)
• 510(K) Information Needed for Hydroxyapatite Coated Orthopedic Implants (1997-02-19) (catalog)
• Third Party Review Guidance for Phacofragmentation System Device Premarket Notification (510(k)) (1997-01-31)
• Third Party Review Guidance For Vitreous Aspiration and Cutting Device Premarket Notification (510(k)) (1997-01-30)
• Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers [excimer] (1996-10-09)
• Suggested Format For IDE Progress Report (1996-05-31) (catalog)
• Thermal Endometrial Ablation Devices (Submission Guidance for an IDE) (1996-03-13)
• Hysteroscopes and Gynecology Laparoscopes - Submission Guidance for a 510(k) (1996-03-07)
• Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities (1995-09-18) (catalog)
• Hysteroscopic and Laparoscopic Insufflators: Submission Guidance for a 510(k) (1995-07-31) (catalog)
• Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles (1995-07-25)
• Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices (1995-07-25)
• Guidance Document for the Preparation of Premarket Notification [510(K)] Applications for Exercise Equipment (1995-07-25)
• Testing Guidance for Male Condoms Made From New Material (Non-Latex) (1995-06-28) (catalog)
• Guidance on the Content and Organization of a Premarket Notification for a Medical Laser (1995-05-31)
• Guidance Document for Testing Non-Articulating, 'Mechanically Locked', Modular Implant Components (1995-04-30)
• Guidance Document For The Preparation of Premarket Notification For Ceramic Ball Hip Systems (1995-01-09)
• Checklist for Mechanical Lithotripters and Stone Dislodgers used in Gastroenterology and Urology (1994-11-01)
• 510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical Instruments (1994-09-18) (catalog)
• Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters (1994-09-11) (catalog)
• Guidance for the Preparation of a Premarket Notification for Extended Laparoscopy Devices (ELD) (1994-08-29)
• Guidance for the Content of Premarket Notifications for Urine Drainage Bags (1994-06-07) (catalog)
• Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone Or Bone Cement (1994-04-27)
• Letter - Manufacturers, Distributors and Importers of Condom Products (included in Condom Packet 398) : Letter - Manufacturers, Distributors and Importers of Condom Products (1994-02-23)
• Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators (1993-09-30)
• Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes (1993-08-01)
• Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities (1993-08-01)
• Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes (1993-03-31) (catalog)
• Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care Facilities (1993-03-01)
• Guidance for the Content of Premarket Notifications for Ureteral Stents (1993-02-09) (catalog)
• Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology (1993-02-09) (catalog)
• Review Criteria For Premarket Approval of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19 (1992-05-15)
• Device Labeling Guidance #G91-1 (Blue Book Memo) (1991-03-07) (catalog)
• Guidance for Oxygen Conserving Device 510(k) Review 73 BZD 868.5905 Non-continuous Ventilator Class II (1989-02-01) (catalog)
• Master Files Part III - Guidance on Scientific and Technical Information (1987-06-01)
• All U.S. Condom Manufacturers, Importers and Repackagers (1987-04-07)
• Guidance ('Guidelines') for Evaluation of Hysteroscopic Sterilization Devices (1978-05-09)
• Review Guidelines for Oxygen Generators and Oxygen Equipment for Emergency Use (1977-01-01) (catalog)

Quality / QMSR / Manufacturing

7 documents, 6 with full text.

• Remanufacturing of Medical Devices: Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff (2024-05-10)
• Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program: Guidance for Industry and Food and Drug Administration Staff (2023-09-15)
• Inspection and Field Testing of Radiation-Emitting Electronic Products: Attachment C: Specific Instructions for Sunlamp Product Inspections and Tests (2007-10-30)
• Inspection and Field Testing of Radiation-Emitting Electronic Products: Attachment A (2007-10-30) (catalog)
• Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors - Three Additional Questions: Guidance for Industry, FDA Staff, Third-Party and Hospital Reprocessors (2003-07-16)
• Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals: Final Guidance for Industry and FDA (2001-07-30)
• Quality Assurance Guidelines for Hemodialysis Devices (1991-02-01)

IVD / Companion Diagnostics

7 documents, 7 with full text.

• Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency: Guidance for Industry and Food and Drug Administration Staff (2025-09-23)
• Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices: Guidance for Industry and FDA Staff (2022-08-17)
• Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff (2020-02-26)
• Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) - Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases: Guidance for Stakeholders and Food and Drug Administration Staff (2018-04-13)
• Administrative Procedures for CLIA Categorization: Guidance for Industry and Food and Drug Administration Staff (2017-10-02)
• Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff (2014-08-27)
• Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses - Guidance for Industry and FDA Staff (2011-07-14)

Labeling / UDI

14 documents, 14 with full text.

• Global Unique Device Identification Database (GUDID): Guidance for Industry and Food and Drug Administration Staff (2024-12-17)
• Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment: Guidance for Industry and Food and Drug Administration Staff (2024-09-27)
• Antimicrobial Susceptibility Test (AST) System Devices – Updating Breakpoints in Device Labeling: Guidance for Industry and Food and Drug Administration Staff (2023-09-29)
• Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices: Guidance for Industry and Food and Drug Administration Staff (2022-07-25)
• Surgical Staplers and Staples for Internal Use - Labeling Recommendations: Guidance for Industry and Food and Drug Administration Staff (2021-10-08)
• Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI): Guidance for Industry and Food and Drug Administration Staff (2021-07-07)
• Unique Device Identification: Convenience Kits : Guidance for Industry and Food and Drug Administration Staff (2019-04-26)
• Unique Device Identification: Direct Marking of Devices : Guidance for Industry and Food and Drug Administration Staff (2017-11-17)
• Unique Device Identifier System: Frequently Asked Questions, Vol. 1 : Guidance for Industry and Food and Drug Administration Staff (2014-08-20)
• Addition of URLs to Electronic Product Labeling: Guidance for Industry and FDA Staff (2010-09-29)
• Approval of Alternate Means of Labeling for Laser Products (Laser Notice 53) (2007-03-22)
• Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended – Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices: Guidance for Industry and FDA Staff (2006-05-01)
• Guidance on Medical Device Patient Labeling: Final Guidance for Industry and FDA Staff (2001-04-19)
• Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203) (1989-09-01)

Postmarket / Recalls / Vigilance

25 documents, 23 with full text.

• Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act: Guidance for Industry and Food and Drug Administration Staff (2025-01-07)
• Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers: Guidance for Industry and Food and Drug Administration Staff (2024-08-29)
• Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices: Guidance for Industry and Food and Drug Administration Staff (2023-11-03)
• Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff (2022-10-07)
• Nonbinding Feedback After Certain FDA Inspections of Device Establishments: Guidance for Industry and Food and Drug Administration Staff (2020-04-22)
• Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request: Guidance for Industry and Food and Drug Administration Staff (2017-10-30)
• Public Notification of Emerging Postmarket Medical Device Signals ("Emerging Signals"): Guidance for Industry and Food and Drug Administration Staff (2016-12-14)
• Medical Device Reporting for Manufacturers : Guidance for Industry and Food and Drug Administration Staff (2016-11-08)
• Distinguishing Medical Device Recalls from Medical Device Enhancements: Guidance for Industry and Food and Drug Administration Staff (2014-10-15)
• Medical Device Tracking : Guidance for Industry and FDA Staff (2014-03-27)
• Questions and Answers about eMDR - Electronic Medical Device Reporting - Guidance for Industry, User Facilities and FDA Staff (2014-02-13)
• Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use (2008-12-23)
• Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination Gloves: Guidance for Industry and FDA Staff (2008-07-11)
• Surveillance and Detention Without Physical Examination of Condoms: Guidance for Industry and FDA Staff (2008-07-11)
• Writing Dear Doctor Letters for Recalls of Implantable Cardioverter Defibrillators (ICDs): Guidance for Industry and FDA Staff (2007-07-19)
• Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment: Guidance for Industry and FDA Staff (2006-03-10)
• Review Criteria for Assessment of C-Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Assays: Guidance for Industry and FDA Staff (2005-09-22)
• Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems - Guidance for Industry and FDA Staff (2003-09-04)
• Needlesticks - Medical Device Reporting Guidance for User Facilities, Manufacturers, and Importers (2002-11-11)
• Sterilized Convenience Kits for Clinical and Surgical Use: Final Guidance for Industry (2002-01-07)
• Information for Keratome Manufacturers Regarding LASIK - Final Guidance for Industry (2001-06-20)
• Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements - Guidance for Industry and for FDA Reviewers/Staff (2000-02-01)
• Variance from Manufacturer Report Number Format - No. 5 (1996-08-11) (catalog)
• Variance from Manufacturer Report Number Format [MDR letter] (1996-07-15) (catalog)
• Medical Device Reporting for User Facilities (1996-04-01)

Radiation / Imaging

44 documents, 21 with full text.

• Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Referring Provider Notification Orders: Guidance for Mammography Facilities and Food and Drug Administration Staff (2024-09-10)
• Acceptable Media for Electronic Product User Manuals: Guidance for Industry and FDA Staff (2024-08-19)
• Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56): Guidance for Industry and Food and Drug Administration Staff (2023-02-21)
• Guidance for Industry and Food and Drug Administration Staff - Assembler's Guide to Diagnostic X-Ray Equipment (2023-02-21)
• Surveying, Leveling, and Alignment Laser Products: Guidance for Industry and Food and Drug Administration Staff (2023-01-31)
• Policy Clarification for Certain Fluoroscopic Equipment Requirements: Guidance for Industry and Food and Drug Administration Staff (2019-05-08)
• Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57): Guidance for Industry and Food and Drug Administration (2019-05-08)
• Minimizing Risk for Children's Toy Laser Products: Guidance for Industry and Food and Drug Administration Staff (2014-12-19)
• Procedures for Renewal and Amendment of Certain Laser Light Show Variances (Laser Notice 55) (2007-09-24)
• Compliance Guide for Cabinet X-Ray Systems (2007-09-18)
• Exemption from Reporting and Recordkeeping Requirements for Low Power Laser Products (Laser Notice 54): Guidance for Industry and FDA Staff (2006-01-05)
• Applicability of the Performance Standard for High-Intensity Mercury Vapor Discharge Lamps (21 CFR 1040.30) (2005-11-05)
• Guidance on the Department of Defense Exemption from the FDA Performance Standard for Laser Products: Guidance for Industry and FDA (2002-07-12)
• Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors; (Laser Notice 51) (2001-05-26)
• Accidental Radioactive Contamination of Human Food and Animal Feeds: Recommendations for State and Local Agencies (1998-08-13)
• Identification Labels for Certain Class I Laser Products (Laser Notice 48) (1996-09-05) (catalog)
• Emitted Laser Beam as Emission Indicator for Class II and Class IIIa Laser Products (Laser Notice 49) (1996-09-05) (catalog)
• Effective Visual Control of Laser Projections (Laser Notice 47) (1996-06-06) (catalog)
• User Instruction for Medical Products (Laser Notice 44) (1995-08-11) (catalog)
• Beam Attenuators and Emission Indicators for Class II and IIIa Laser Systems (Laser Notice 43) (1993-06-07) (catalog)
• Compliance Guide for Laser Products (FDA 86-8260) (1992-06-01)
• Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 3) (1989-03-01) (catalog)
• Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 1 ) (1989-03-01) (catalog)
• Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (FDA 89-8221) (1989-02-28) (catalog)
• Quality Control Guide for Sunlamp Products (FDA 88-8234) (1988-03-01)
• [Guide for Establishing and Maintaining a Calibration Constancy Intercomparison System for Microwave Oven Compliance Survey Instruments (FDA 88-8264)] (PDF Only)](./guidance/guide-establishing-and-maintaining-calibration-constancy-intercomparison-system-microwave-oven) (1988-03-01)
• Class II and IIIA Laser Light Show Projectors and Shows (Laser Notice 40) (1987-10-29) (catalog)
• User Instructions - Multi Axis Workstations (Laser Notice 39) (1987-06-24) (catalog)
• Walk-In Workstations (Laser Notice 37) (1985-10-21) (catalog)
• Policy On Maximum Timer Interval and Exposure Schedule For Sunlamp Products (1985-08-21)
• Policy on Warning Label Required on Sunlamp Products (1985-06-25)
• User Instruction Hazard Warnings (Laser Notice 35) (1985-02-05) (catalog)
• Medical Laser Delivery System Interlocks (Laser Notice 34) (1985-01-20) (catalog)
• Exemption from Reporting and Record keeping Requirements for Certain Sunlamp Product Manufacturers (1981-09-16)
• Investigational Medical Laser Significant Risk Device (Laser Notice 31) (1981-05-18) (catalog)
• Alternate Wording For Caution Statement (Laser Notice 30) (1980-08-25) (catalog)
• Laser Light Shows Subject to Laser Product Performance Standard (Laser Notice 22) (1977-11-23) (catalog)
• Warning Labels For Dye And Multiple Wavelength Lasers (Laser Notice 16) (1977-03-02) (catalog)
• Lasers Manufactured and Used In-House (Laser Notice 14) (1976-11-23) (catalog)
• Manufacture and Certification of Laser Kits (Laser Notice 13) (1976-10-14) (catalog)
• Remote Interlock Connectors (Laser Notice 11) (1976-10-07) (catalog)
• Viewing Optics - Sighting Telescope (Laser Notice 8) (1976-08-05) (catalog)
• Quality Control Practices for Compliance with the Federal Laser Performance Standard (1976-03-01) (catalog)
• Laser Energy Source (Laser Notice 2) (1975-11-21) (catalog)

Clinical / Real-World Evidence

3 documents, 3 with full text.

• Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials (2010-02-04)
• Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests - Guidance for Industry and FDA Staff (2007-03-12)
• Recommended Clinical Study Design for Ventricular Tachycardia Ablation (1999-05-07)

General / Other

21 documents, 19 with full text.

• Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle: Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties (2026-03-30)
• Medical Device User Fee Small Business Qualification and Determination: Guidance for Industry, Food and Drug Administration Staff and Foreign Governments (2025-07-31)
• Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder: Guidance for Industry and Food and Drug Administration Staff (2024-07-11)
• Referencing the Definition of "Device" in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents: Guidance for Industry and Food and Drug Administration Staff (2022-11-14)
• Policy for Monkeypox Tests to Address the Public Health Emergency: Guidance for Laboratories, Commercial Manufacturers and Food and Drug Administration Staff (2022-09-07)
• Center for Devices and Radiological Health (CDRH) Appeals Processes: Guidance for Industry and Food and Drug Administration Staff (2022-03-02)
• Recognition and Withdrawal of Voluntary Consensus Standards: Guidance for Industry and Food and Drug Administration Staff (2020-09-15)
• Providing Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff (2020-07-15)
• Implanted Blood Access Devices for Hemodialysis: Guidance for Industry and Food and Drug Administration Staff (2016-01-21)
• Impact-Resistant Lenses: Questions and Answers: Guidance for Industry and FDA Staff (2010-09-02)
• Decorative, Non-corrective Contact Lenses: Guidance for Industry, FDA Staff, Eye Care Professionals, and Consumers (2006-11-24)
• Pediatric Expertise for Advisory Panels - Guidance for Industry and FDA Staff (2003-06-02)
• Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997 - Guidance for Industry and for FDA Reviewers (2000-08-08)
• 1-Consolidated Annual Report for a Device product line (1-CARD) - Guidance for Industry and CDRH Reviewers (2000-07-05)
• FDA Animal Products Database Data Entry Form (1998-11-06) (catalog)
• Prospective Manufacturers of Barrier Devices Used During Oral Sex for STD Protection (1996-10-30)
• Points to Consider for Cervical Cytology Devices (1994-07-25)
• Letter to Industry, Powered Wheelchair Manufacturers from RMJohnson (1993-05-10) (catalog)
• Shelf Life of Medical Devices (1991-04-01)
• Color Additive Petitions - Medical Devices (1987-06-01)
• Policy on Lamp Compatibility (sunlamps) (1986-09-02)