FDA 510(k) Submission Overview

FDA Reference: 21 CFR 807.87, eSTAR Template v7.0
Document Code: FDA-COVER
Responsible Party: Manufacturer / US Agent

Requirements Checklist

Cover Letter & Administrative Information

• [ ] Applicant name and address
• [ ] Contact person information
• [ ] Submission type: Traditional / Abbreviated / Special 510(k) / De Novo
• [ ] Device trade name and common name
• [ ] Device classification: product code, regulation number, device class
• [ ] Predicate device(s) identification (for 510(k))
• [ ] Fee payment information (user fee cover sheet, MDUFA)
• [ ] Truthful and Accurate statement signed by responsible person
• [ ] Pre-submission correspondence reference (if applicable)

Section 3: Indications for Use Statement

• [ ] Device name
• [ ] Indications for use statement (per FDA-prescribed format)
• [ ] Prescription use / OTC / Prescription and OTC
• [ ] Enclosure type (class II only): Special Controls referenced

Section 4: 510(k) Summary or Statement

510(k) Summary (21 CFR 807.92) -- choose one:

• [ ] Submitter contact information
• [ ] Device description, intended use, technological characteristics
• [ ] Predicate device comparison
• [ ] Summary of non-clinical tests and clinical data
• [ ] Conclusions drawn from non-clinical and clinical data

OR 510(k) Statement (21 CFR 807.93):

• [ ] Statement that safety and effectiveness information will be made available within 30 days of request

Section 10: Substantial Equivalence (SE) Comparison

• [ ] Predicate device identification (510(k) number, device name, manufacturer)
• [ ] Comparison of intended use / indications for use
• [ ] Comparison of technological characteristics
• [ ] For different technological characteristics: demonstrate no new questions of safety/effectiveness
• [ ] Performance comparison data summary
• [ ] SE determination rationale

Section 11: Device Description

• [ ] Comprehensive device description
• [ ] Principles of operation
• [ ] Physical characteristics (dimensions, materials, components)
• [ ] Software description (if applicable): level of concern, version, operating platform
• [ ] Diagrams, photographs, engineering drawings
• [ ] Comparison table with predicate device

Section 12: Standards & Conformance

• [ ] List of recognised consensus standards used (with declaration of conformity)
• [ ] For each standard: full compliance or partial compliance with explanation
• [ ] Summary of test methods and results per standard
• [ ] For Abbreviated 510(k): identify guidance documents, special controls, or standards relied upon

Section 13: Proposed Labeling

• [ ] Instructions for Use (IFU)
• [ ] Device labels (all packaging levels)
• [ ] Patient labeling (if applicable)
• [ ] Promotional materials (if applicable)
• [ ] QMSR terminology compliance (Design and Development File, Medical Device File) -- effective February 2, 2026

Section 14: Sterilization & Shelf Life

• [ ] Sterilization method and validation (if applicable)
• [ ] Bioburden testing
• [ ] Sterility Assurance Level (SAL)
• [ ] Pyrogenicity testing (if applicable)
• [ ] Shelf life / expiration dating studies
• [ ] Package integrity testing
• [ ] Transportation / distribution testing

Section 15: Biocompatibility

• [ ] Biocompatibility evaluation per ISO 10993-1
• [ ] Device categorization: contact type and duration
• [ ] Biological endpoint evaluation matrix
• [ ] Testing results or justification for test exemption
• [ ] Material characterization (chemical, physical)
• [ ] Toxicological risk assessment (if applicable)

Section 16: Software Documentation

• [ ] Software level of concern: Minor / Moderate / Major
• [ ] Software description and architecture (SOUPregistry)
• [ ] Software development lifecycle (IEC 62304)
• [ ] Software requirements specification
• [ ] Software design specification
• [ ] Software testing (unit, integration, system, acceptance)
• [ ] Revision history and version control
• [ ] Cybersecurity documentation (if applicable):
  • Threat model and risk assessment
  • Design inputs/outputs for security
  • SBOM (Software Bill of Materials)
  • Vulnerability assessment and penetration testing
  • Patch management plan
• [ ] For AI/ML: Predetermined Change Control Plan (PCCP)

Section 17: EMC / Electrical Safety

• [ ] IEC 60601-1 compliance (general safety and essential performance)
• [ ] IEC 60601-1-2 compliance (EMC requirements)
• [ ] Applicable collateral and particular standards
• [ ] Risk management file per IEC 60601-1 Clause 4
• [ ] Essential performance identification

Section 18: Performance Testing

• [ ] Bench testing per applicable standards
• [ ] Performance test protocols and results
• [ ] Comparison with predicate device performance (where applicable)
• [ ] Animal testing (if applicable, with IACUC approval)
• [ ] Simulated-use testing

Section 19: Human Factors / Usability (eSTAR v7.0 Update)

• [ ] Human factors evaluation strategy per FDA HF Guidance (effective August 1, 2026)
• [ ] Preliminary analysis and task analysis
• [ ] Formative evaluation results
• [ ] Summative (validation) evaluation results
• [ ] Root cause analysis for critical use errors
• [ ] Labeling comprehension testing (if applicable)

Section 20: Clinical Data

• [ ] Clinical data requirement determination
• [ ] If clinical data required:
  • Clinical study reports
  • Published literature
  • Adverse event database analysis (MAUDE)
  • Real-World Evidence analysis (aligned with RWE guidance, February 2026)
• [ ] If clinical data not required: justification

Key Regulatory References

• 21 CFR Part 807, Subpart E: Premarket Notification Procedures
• 21 CFR Part 820 (QMSR, effective February 2, 2026)
• eSTAR Program
• FDA Guidance: "The 510(k) Program -- Evaluating Substantial Equivalence"
• FDA Guidance: "Refuse to Accept Policy for 510(k)s"
• FDA Guidance: "Content of Premarket Submissions for Device Software Functions" (2023)
• FDA Guidance: "Cybersecurity in Medical Devices" (2023)
• FDA Guidance: "Human Factors Content" (effective August 1, 2026)
• FDA Guidance: "Use of Real-World Evidence" (effective February 16, 2026)