Electronic Submission Template for Medical Device De Novo Requests: Guidance for Industry and Food and Drug Administration Staff
Published: 2024-08-23
Status: Final Type: Guidance Document Category: Premarket (510(k) / PMA / De Novo / IDE) Topics: Premarket, Electronic Submissions Docket: FDA-2023-D-3788
Official Source
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-template-medical-device-de-novo-requests PDF: https://www.fda.gov/media/172450/download
Official Full Text
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page.
I. Introduction
The Food and Drug Administration (FDA or Agency) is issuing this guidance document to introduce submitters of De Novo requests1 to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) to the current resources and associated content developed and made publicly available to support De Novo electronic submissions to FDA. This guidance is intended to represent one of several steps in meeting FDA’s commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process.2 This guidance facilitates the implementation of the FDA’s mandate under section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), amended by section 207 of the FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115-523) to provide further standards for the submission by electronic format, a timetable for establishment of these further standards, and criteria for waivers of and exemptions from the requirements. FDA’s guidance document “Providing Regulatory Submissions for Medical Devices in Electronic Format — Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act” (hereafter referred to as the “745A(b) device parent guidance”) provides a process for the development of templates to facilitate the preparation, submission, and review of regulatory submissions for medical devices solely in electronic format. As described in the Reauthorization), also available at https://www.fda.gov/media/102699/download, 168 CONG. REC. S5194-S5203 (daily ed. September 28, 2022) (Food and Drug Administration User Fee Reauthorization), also available at https://www.fda.gov/media/158308/download and 168 CONG. REC. S5194-S5203 (daily ed. September 28, 2022) (Food and Drug Administration User Fee Reauthorization), also available at https://www.fda.gov/media/158308/download In section 745A(b)(3) of the FD&C Act, Congress granted explicit statutory authorization to FDA to specify in guidance the electronic submissions requirement by providing standards, criteria for waivers and exemptions, and a timetable for such submissions. Accordingly, to the extent that this document provides such requirements under section 745A(b)(3) of the FD&C Act, indicated by the use of mandatory words, such as must or required, this guidance is not subject to the usual restrictions in section 701(h) of the FD&C Act and FDA’s good guidance practices (GGPs) regulations, such as the requirement that guidances not establish legally enforceable responsibilities. See 21 CFR 10.115(d). This document provides guidance on FDA’s interpretation of the statutory requirement for electronic submissions solely in electronic format. Therefore, to the extent that this guidance describes recommendations that are not “standards,” “timetable,” or “criteria for waivers” and “exemptions” under section 745A(b)(3) of the FD&C Act, this document does not create or confer any rights for or on any person and does not operate to bind FDA or the public, but does represent the Agency’s current thinking on this topic. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff listed on the title page of this guidance. To comply with the GGP regulations and make sure that regulated entities and the public understand that guidance documents are nonbinding, FDA guidances ordinarily contain standard language explaining that guidances should be viewed only as recommendations unless specific regulatory or statutory requirements are cited. This guidance contains both binding and nonbinding provisions. Insofar as this guidance provides “standards,” “timetable,” or “criteria for waivers” and “exemptions” pursuant to section 745A(b) of the FD&C Act, it will have a binding effect. For those provisions not identified as binding, the contents of this document are not intended to have the force and effect of law. This document, other than the binding provisions, is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
II. Background
Section 745A(b) of the FD&C Act, amended by section 207 of FDARA, requires that presubmissions and submissions for devices under section 510(k), 513(f)(2)(A), 515(c), 515(d), 515(f), 520(g), 520(m), or 564 of the FD&C Act or section 351 of the Public Health Service Act, and any supplements to such pre-submissions or submissions, including appeals of those submissions, be submitted in electronic format specified by FDA beginning on such date as specified by FDA in final guidance. It also mandates that FDA issue draft guidance not later than October 1, 2019, and a final guidance not later than 1 year after the close of the public comment period, providing for further standards for the submission by electronic format, a timetable for establishment of these further standards, and criteria for waivers of and exemptions from the requirements.4 In addition, in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter5 from the Secretary of Health and Human Services to Congress, FDA committed to developing “electronic submission templates that will serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process” and “[by] FY [fiscal year] 2020, the Agency will issue a draft guidance document on the use of the electronic submission templates.” In addition, the MDUFA IV Commitment Letter states that “[n]o later than 12 months after the close of the public comment period, the Agency will issue a final guidance.” The 745A(b) device parent guidance was intended to satisfy the final guidance documents referenced in section 745A(b)(3) of the FD&C Act and the MDUFA IV Commitment Letter. The Medical Device User Fee Amendments of 2022 (MDUFA V) Commitment Letter affirmed FDA’s commitment to the continued development of electronic submission templates for a variety of premarket submission types.6 In February 2020, CDRH piloted the use of the electronic Submission Template And Resource (eSTAR) electronic submission template for 510(k)s through launching the eSTAR Pilot Program.7 CBER piloted the use of eSTAR for 510(k)s in June 2022.8 The eSTAR template became available for voluntary use by all 510(k) submitters in September 2020. Mandatory use of the eSTAR template for 510(k) submissions began in October 2023. In January 2022, CDRH expanded the eSTAR template to include the ability to submit content for De Novo requests. During the transition time up to the point when De Novo electronic submissions will be required (see Section VI.B below), anyone can voluntarily use eSTAR for submission of De Novo requests. As described below, eSTAR is the only electronic submission template currently available to enable De Novo electronic submissions.
III. Scope
This guidance describes the technical standards associated with preparation of the electronic submission template for De Novo classification requests9 that enable submission of the De Novo electronic submission solely in electronic format. The electronic submission template includes Reauthorization), also available at https://www.fda.gov/media/102699/download Reauthorization), also available at https://www.fda.gov/media/158308/download Novo electronic format and standards for complying with section 745(A)(b)(3) of the FD&C Act. FDA intends to implement new versions of eSTAR as relevant policies change. FDA also has an ongoing process to collect and consider public comments and stakeholder feedback, which is described on FDA’s website.11
IV. Significant Terminology
For the purpose of this document the following significant terminology is described: eCopy: An electronic copy is a duplicate device submission in electronic format of the previously required paper copy submission sent to FDA.12 An electronic copy is not considered to be an electronic submission, as defined below. Electronic Submission (eSubmission): The submission package produced by an electronic submission template13 that contains the data of a ‘complete’14 submission. eSTAR (electronic Submission Template And Resource): An electronic submission template15 built within a structured dynamic PDF that guides a user through construction of an eSubmission. eSTAR is the only type of electronic submission template that is currently available to facilitate the preparation of De Novo requests as eSubmissions. For simplicity, the electronic submission created with this electronic submission template is often referred to as an eSTAR. Electronic submission template: A guided submission preparation tool for industry. An electronic submission template walks industry through the relevant contents and components for the respective premarket submission type and device to facilitate submission preparation and enhance consistency, quality, and efficiency in the premarket review process.16 Structured data: Data and content that are captured in the fields, dropdown boxes, checkboxes, etc., within the electronic submission template. Unstructured data: Data and content that are submitted as attachments to the electronic submission template. 15 The De Novo eSTAR can be downloaded for free on FDA’s website at https://www.fda.gov/medicaldevices/how-study-and-market-your-device/voluntary-estar-program
V. Current Electronic Submission Template Structure, Format, and Use
The electronic submission template, eSTAR, is the only currently available electronic submission template at this time to facilitate the preparation of De Novo electronic submissions. eSTAR consists of a collection of questions, text, logic, and prompts within a template that guides a user through construction of a ‘complete’ De Novo17 request. eSTAR is highly automated, includes integrated databases (e.g., FDA product codes, FDA-recognized voluntary consensus standards), and includes targeted questions designed to collect specific data and information from the submitter. eSTAR also includes applicable links to regulations, relevant guidances, and other resources for the submitter’s reference. Finally, eSTAR is structured to collect and assemble content in the De Novo request as an electronic submission that closely follows the content of the “SMART” De Novo review memo template used by FDA reviewers. Given that an electronic submission properly prepared with an electronic submission template should represent a complete submission,18 the acceptance review under 21 CFR 860.230 has been largely automated within the eSTAR.19 However, FDA intends to employ a virus scanning and technical screening process for an eSTAR as part of the acceptance review process. A technical screening process is a process for verifying that eSTAR responses are consistent with descriptions of the device(s) (e.g., there are, in fact, no tissue contacting components if indicated as such) and that there is at least one relevant attachment per each applicable attachment-type question (e.g., a Software Description attachment is included in response to the Software Description question if software is applicable to the submission). A completed eSTAR submission and the use of the technical screening process incorporates the acceptance review criteria described in 21 CFR 860.230(c)(1)(i) through (v). As part of considering these criteria, FDA staff should determine whether the subject device is a device type for which De Novo classification is known to be an inappropriate regulatory approach. If the device does not appear to be eligible for De Novo classification (e.g., a predicate device exists, an existing classification regulation exists for the same device type, or an approved PMA(s) exists for the same device type), FDA staff should make this determination during the technical screening process. The technical screening process is not intended to identify De Novo requests for which a substantive review is required in order to determine if De Novo classification is an inappropriate approach (e.g., FDA staff need to conduct a substantive review of information in the request to research and analyze De Novo eligibility or to determine if special controls can mitigate the identified risks to health). If FDA determines the device is ineligible during the technical screening process, FDA considers this to be a basis for placing the De Novo request on hold (see section 513(f)(2) of the FD&C Act, 21 CFR 860.200, 21 CFR 860.230(c)(1)(ii), and 83 FR 63128). 18 After submitters complete all necessary sections in their eSTAR file correctly, the status message at the top of the PDF will indicate “eSTAR Complete” to represent a complete submission. Review for De Novo Classification Requests”. Additionally, in evaluating the criterion described in 21 CFR 860.230(c)(1)(iv) FDA staff should also consider if the De Novo request is for devices of more than one type. It may be appropriate for FDA to review multiple devices in a single marketing submission under certain circumstances.20 For example, it may be appropriate for multiple sizes of a device to be reviewed together in a De Novo request and classified together as the same type of device under a single regulation. However, if a De Novo requester is instead proposing that multiple device types be classified under a single De Novo request (e.g., a submission for a device with multiple proposed indications or technologies that each have different benefit-risk considerations and supporting datasets would likely constitute more than one device type), the De Novo request should be placed on hold (see 21 CFR 860.230(c)(1)(iv)) and the review team should work with the De Novo requester to clarify which device type should be the subject of the De Novo request. This helps ensure efficient use of FDA resources by confining the scientific and regulatory issues in a submission to a single classification decision so that FDA can render a timely decision and assess user fees appropriately. The technical screening process should occur within 15 calendar days of FDA receiving the De Novo eSTAR.21 FDA will only begin the technical screening for De Novo electronic submissions where the appropriate user fee has been paid. If the eSTAR is not complete when submitted, FDA will notify the submitter via email22 and identify the incomplete information, and the De Novo will be placed on hold. If a replacement eSTAR is not received within 180 days of the date of technical screening deficiency notification, FDA will consider the De Novo to be withdrawn and the submission will be closed in the system.23 The technical screening review time does not impact the review clock for files that pass the technical screening. For a submission that passes technical screening, the review clock starts on the day the submission was received by FDA. Once the eSTAR passes technical screening and the De Novo submission is accepted, FDA will notify the requester electronically.24 If FDA does not complete the technical screening within the acceptance review period (i.e., within 15 calendar days of receipt), FDA will accept the De Novo request for review and will notify the requester.25
A. Structure of the Current De Novo Electronic Submission Template
Regulatory Communications”. Use of Email for Regulatory Communications”. In Table 1 below, is a high-level overview of the structure of the current electronic submission template for De Novos,26 including a summary of the anticipated submission content provided by the submitter in each section:27 Table 1: Structure of the current eSTAR De Novo Electronic Submission Template Information Requested Description Submission Type Identification of key information that may be useful to FDA in the initial processing and review of the De Novo request, including content from current Form FDA 3514, Section A.28 Cover Letter / Letters of Reference Attach a cover letter and any documents that refer to other submissions. Applicant29 Information Information on applicant and correspondent, if applicable, consistent with content from current Form FDA 3514, Sections B and C (see 21 CFR 860.220(a)(2)). Pre-Submission Correspondence & Previous Regulator Interaction Information on prior or ongoing submissions for the same device included in the current submission, such as submission numbers for a prior not substantially equivalent (NSE) determination, prior deleted or withdrawn 510(k), Q-Submission, Investigational Device Exemption (IDE) application, premarket approval (PMA) application, humanitarian device exemption (HDE) application, De Novo classification request, requests for information under section 513(g) of the FD&C Act, or applications for emergency use authorization (EUA) (see 21 CFR 860.220(a)(3)). Consensus Standards30 Identification of voluntary consensus standard(s) used, if applicable. This includes both FDA-recognized and nonrecognized consensus standards (see 21 CFR 860.220(a)(12)). 26 As indicated above, FDA intends to employ a technical screening process to verify that electronic submission template responses accurately describe the device. 27 Throughout completion of the eSTAR, submitters can add attachments as unstructured data, including documents, PDFs, images, and videos that submitters believe are pertinent to the review of their device. In addition, eSTAR will prompt for any documents that are needed. For example, when the use of clinical testing to support the submission is affirmatively indicated, eSTAR will automatically prompt for the attachment of clinical testing documents and any applicable financial certifications or disclosure statements. These attachments appear within the applicable bookmark of the eSTAR PDF when viewed by the submitter or FDA. Information Requested Description Device Description Identification of listing number if listed with FDA. Descriptive information for the device, in accordance with 21 CFR 860.220(a)(6). Descriptive information also includes a description of the principle of operation for achieving the intended effect and the proposed conditions of use, such as surgical technique for implants; anatomical location of use; user interface; how the device interacts with other devices; and/or how the device interacts with the patient. A description of existing alternative practices or procedures used in diagnosing, treating, preventing, curing, or mitigating the disease or condition for which the device is intended or which similarly affect the structure and function of the body. Otherwise, provide a statement if there are no known or reasonably known alternative practices or procedures (see 21 CFR 860.220(a)(7)). Information on whether the device is intended to be marketed with accessories. If a Request for Designation (RFD) number exists, provide the RFD number that established that the device or combination product being submitted was assigned to CDRH or CBER (see 21 CFR 860.220(a)(3)). Proposed Indications for Use Identification of the proposed indications for use of the device. The term indications for use, as defined in 21 CFR 860.220(a)(5), is “a general description of the disease or condition the device is intended to diagnose, treat, prevent, cure or mitigate, or affect the structure or function of the body, including a description of the patient population for which the device is intended. The indications for use include all the labeled patient uses of the device, including if it is prescription or over-the-counter.” Classification Identification of the proposed classification (Class I or II) that seems most appropriate for the subject device (see 21 CFR 860.220(a)(11)). Provide classification summary information, in accordance with 21 CFR 860.220(a)(8)). Information Requested Description Benefits, Risks, and Mitigation Measures A summary of the probable risks to health associated with use of the device that are known or should reasonably be known to you and the proposed mitigations, including general controls and, if applicable, special controls for each risk (see 21 CFR 860.220(a)(9)). If the proposed classification recommendation is class II, proposed special controls to mitigate the risks to health associated with use of the device, in accordance with 21 CFR 860.220(a)(10). A discussion demonstrating that the data and information in the De Novo request constitute valid scientific evidence within the meaning of 21 CFR 860.7(c), and pursuant to 21 CFR 860.7, when subject to general controls or general and special controls, the probable benefits to health from use of the device outweigh any probable injury or illness from such use (see 21 CFR 860.220(a)(14) and FDA guidance “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications”). Labeling Submission of proposed labeling in sufficient detail to satisfy the requirements of 21 CFR 860.220(a)(18). Generally, if the device is an in vitro diagnostic device, the labeling must also satisfy the requirements of 21 CFR 809.10. Additionally, the term “labeling” generally includes the device label, instructions for use, and any patient labeling (see sections 201(k) and (m) of the FD&C Act and FDA guidance “Guidance on Medical Device Patient Labeling”). Reprocessing* Information for assessing the reprocessing validation and labeling, if applicable (see FDA guidance “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling”). Sterility* Information on sterility and validation methods, if applicable. Shelf Life* Summary of methods used to establish that device performance is maintained for the entirety of the proposed shelf-life (e.g., mechanical properties, coating integrity, pH, osmolality), if applicable (see FDA guidance “Shelf Life of Medical Devices”). Biocompatibility* Information on the biocompatibility assessment of patient contacting materials, if applicable (see FDA guidance “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process’”). Information Requested Description Software/Firmware Submission of applicable software documentation, if applicable (see 21 CFR 860.220(a)(15)(ii) and FDA guidance “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”). Cybersecurity/Interoperability* Submission of applicable information regarding the assessment of cybersecurity, if applicable (see FDA guidance “Content for Premarket Submissions for Management of Cybersecurity in Medical Devices” and “Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices”). Electromagnetic Compatibility (EMC), Electrical, Mechanical, Wireless and Thermal Safety* Submission of the EMC, Electrical, Mechanical, Wireless and Thermal Safety testing for your device or summarize why testing is not needed (see FDA guidance “Electromagnetic Compatibility (EMC) of Medical Devices” and “Radio Frequency Wireless Technology in Medical Devices”). Performance Testing*^ For non-in vitro diagnostic devices: Provide information on the non-clinical and clinical test reports submitted, referenced, or relied on in the De Novo to demonstrate that general controls or general and special controls are sufficient to provide a reasonable assurance of safety and effectiveness (see FDA guidance “Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions”). For in vitro diagnostic devices: Provide analytical performance, comparison studies, reference range/expected values, and clinical study information to demonstrate that general controls or general and special controls are sufficient to provide a reasonable assurance of safety and effectiveness. References Inclusion of any literature references in accordance with 21 CFR 860.220(a)(16). Administrative Documentation Inclusion of additional administrative forms applicable to the submission, including but not limited to a general summary of submission/executive summary (recommended). Amendment/Additional Information (AI) response Inclusion of responses to Additional Information requests.31 31 While the responses to FDA additional information requests are included in this section, submitters should include the actual changes to the information to be reviewed by FDA in the respective section of eSTAR (e.g., updated draft labeling should be included in the Labeling section).
- The information in eSTAR for these sections is intended to fulfill the requirements of 21 CFR 860.220(a)(13) and 21 CFR 860.220(a)(15)(i). ^ The information in eSTAR for this section is intended to fulfill the requirements of 21 CFR 860.220(a)(15)(iii).
VI. Electronic Submission Template Waivers, Exemptions, and Timing
With this final guidance, all submissions for De Novo requests, including original, Supplements and Amendments (amendments include add-to-files and appeals),32 and any other subsequent submissions to an original submission unless exempted below in Section VI.A of this guidance, are required to be submitted as electronic submissions as of the implementation date. A De Novo request that is not provided as an electronic submission as of that date and as described in Section V above, will not be received unless an exemption from the electronic submission requirements or a waiver with respect to that submission applies.
A. Waivers and Exemptions From Electronic Submission Requirements
Above, FDA identified that De Novo requests are subject to electronic submission requirements of this final guidance after the implementation date. However, section 745A(b)(2) of the FD&C Act allows for FDA to set forth criteria for exemptions and waivers from electronic submission requirements. FDA has identified such criteria for De Novos below. Exemptions FDA is exempting the following De Novo submissions/information from the De Novo electronic submission requirements: · Interactive review responses;33
- Amendments:34
- Appeals/requests for supervisory review;35
- Substantive summary requests; - Change in correspondent amendments; - Amendments after final decision (i.e., add-to-files); and 32 References to supplements and amendments are generally meant to capture the various submission types that typically occur in association with a De Novo file that is undergoing review or has received a final decision. 33 If the reviewer used interactive review via phone or email, the submitter should reply to the reviewer via email with the requested attachments and additional information. Other responses to requests for additional information must be submitted in eSTAR (see “Amendment/Additional Information (AI) Response” category in Table 1 above). 34 These De Novo amendments remain subject to any applicable eCopy requirements. For more information, see the FDA guidance “eCopy Program for Medical Device Submissions”. 35 Section 745A(b)(3) of the FD&C Act authorizes FDA to also require that appeals be submitted solely in such electronic format as specified by the Agency in guidance. Once FDA develops such a format, FDA intends to update this guidance to specify any further standards for the submission of De Novo appeals by electronic format, the timetable for establishment of such further standards, and any criteria for a waiver from such requirements.
- Withdrawal requests.36 Waivers At this time, FDA has not identified any particular circumstances appropriate for a waiver of the De Novo electronic submission requirements and does not intend to grant requests for waiver. Given the widespread availability of software to enable use of the current De Novo eSTAR PDF (available to download on FDA’s website), all submitters should have the ability to provide a De Novo eSTAR.37
B. When Electronic Submissions Will Be Required
As described in the 745A(b) device parent guidance, this guidance specifies the corresponding timetable(s) for implementation of De Novo electronic submissions. FDA is identifying October 1, 2025, as the date on which the De Novo electronic submission requirements will take effect. This date includes a transition period of a minimum of one year prior to the requirement that all De Novo submissions be provided as electronic submissions. During the transition period, eSTARs may be used voluntarily for submission of De Novo requests. As instructed at the website for the eSTAR Program (under the heading, “How to prepare a submission using eSTAR”38), the electronic submission must be submitted using FDA’s electronic portal when submitted to CDRH. You can submit questions pertaining to the preparation of submission in electronic format to CDRH at OPEQSubmissionSupport@fda.hhs.gov. For electronic submissions to CBER, please refer to Regulatory Submissions in Electronic Format for CBER- Regulated Products on how to submit through the Electronic Submissions Gateway. You can submit questions pertaining to the preparation of submission in electronic format to CBER at ESUBPREP@fda.hhs.gov. 36 Submission withdrawal requests remain subject to any applicable eCopy requirements. For more information, see the FDA guidance “eCopy Program for Medical Device Submissions.” FDA recommends that withdrawal requests be submitted electronically via email or to the CDRH Portal. 37 There are currently known technical reasons that preclude certain electronic submissions via the CDRH Portal. Those impacted submissions should be mailed to the CDRH Document Control Center (DCC). For more information on the known technical reasons, please refer to FDA’s CDRH Portal webpage, available at https://www.fda.gov/medical-devices/industry-medical-devices/send-and-track-medical-device-premarketsubmissions-online-cdrh-portal
Footnotes
[^1]: See section 513(f)(2) of the Federal Food, Drug, and Cosmetic (FD&C) Act and 21 CFR part 860, subpart D.
[^2]: See 163 CONG. REC. S4729-S4736 (daily ed. August 2, 2017) (Food and Drug Administration User Fee
[^3]: https://www.govinfo.gov/content/pkg/PLAW-115publ52/html/PLAW-115publ52.htm 745A(b) device parent guidance, FDA plans to implement the requirements of section 745A(b)(3) of the FD&C Act with individual guidances specifying the formats for specific submissions and corresponding timetables for implementation. This guidance provides such information for De Novo electronic submissions solely in electronic format.
[^4]: See section 745A(b)(3)(B) of the FD&C Act.
[^5]: See 163 CONG. REC. S4729-S4736 (daily ed. August 2, 2017) (Food and Drug Administration User Fee
[^6]: See 168 CONG. REC. S5194-S5203 (daily ed. September 28, 2022) (Food and Drug Administration User Fee
[^7]: See Notice and request for comments, 85 FR 11371 (Feb. 27, 2020), available at https://www.federalregister.gov/d/2020-03945. The FDA eSTAR website is available at https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program
[^8]: See Notice and request for comments, 87 FR 36861 (June 21, 2022), available at https://www.federalregister.gov/documents/2022/06/21/2022-13210/improving-510k-submission-preparation-and- review-center-for-biologics-evaluation-and-research
[^9]: See section 513(f)(2) of the FD&C Act and 21 CFR part 860, subpart D. the information and guided prompts FDA believes will best facilitate the collection and assembly of the necessary elements of a ‘complete’ submission.10 This guidance is not intended to specify the user-interface and detailed content of the eSTAR, but instead is limited to establishing the De
[^10]: See 21 CFR 860.230 and the FDA guidance “Acceptance Review for De Novo Classification Requests”.
[^11]: See FDA’s website on the eSTAR program at https://www.fda.gov/medical-devices/how-study-and-market-your- device/voluntary-estar-program
[^12]: See 84 FR 68334 and the FDA guidance “eCopy Program for Medical Device Submissions”.
[^13]: See 84 FR 68334 and the FDA guidance “eCopy Program for Medical Device Submissions”.
[^14]: See 21 CFR 860.230 and the FDA guidance “Acceptance Review for De Novo Classification Requests”.
[^17]: See 21 CFR 860.230 and the FDA guidance “Acceptance Review for De Novo Classification Requests”.
[^19]: For more information on the acceptance process, please see 21 CFR 860.230 and the FDA guidance “Acceptance
[^20]: See also FDA’s guidance entitled “Bundling Multiple Devices or Multiple Indications in a Single Submission”.
[^21]: 21 CFR 860.230(a).
[^22]: For additional information about email communications with CBER, please see the “SOPP 8119: Use of Email for
[^23]: See 21 CFR 860.250(a)(2).
[^24]: 21 CFR 860.230(a). For additional information about email communications with CBER, please see “SOPP 8119:
[^25]: 21 CFR 860.230(b).
[^29]: As described in the eSTAR PDF, the “Applicant” is also commonly referred to as the “Submitter” or previously “Sponsor” for 510(k)s, but is not necessarily the person who submits the 510(k). The “Applicant” is the proper term for PMAs but is referred to as the “Requester” for De Novos.
[^30]: https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and- conformity-assessment-program