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  3. Device Advice: Comprehensive Regulatory Assistance
  4. How to Study and Market Your Device
  5. Premarket Submissions
  6. Premarket Notification 510(k)
  7. 510(k) Program Pilots
  1. Premarket Notification 510(k)

510(k) Program Pilots

The FDA will periodically initiate pilot programs to help improve consistency and efficiency in 510(k) review. These pilot programs are intended to aid both industry and FDA staff in using resources effectively. This allows the FDA to direct more effort on the review of higher risk devices, which helps reduce total time to decision, and promotes consistency in 510(k) reviews. The programs do not alter the statutory threshold or data requirements for the determination of substantial equivalence.

eSTAR Pilot Program

Voluntary eSTAR Pilot Program

On September 29, 2021, the FDA issued a draft guidance: Electronic Submission Template for Medical Device 510(k) Submissions. The guidance outlines the structure, format, and use of the electronic Submission Template And Resource (eSTAR) for preparing electronic 510(k) submissions. The Notice of Availability (NOA) for this draft guidance will be open for public comments for 60 days under docket number FDA-2021-D-0872. The draft guidance is not for implementation at this time. When finalized, the guidance will represent the current thinking of the FDA on this topic. For more information on requirements for electronic submissions, see the 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”.

The electronic Submission Template And Resource (eSTAR) is a PDF electronic submission template that guides premarket notification (510(k)) submitters through the process of preparing a comprehensive medical device 510(k) submission. This template contains:

  • Automation (for example, form construction, autofilling);
  • Content and structure that is complementary to CDRH internal review templates;
  • Integration of multiple resources (for example, guidances, databases);
  • Guided construction for each submission section; and
  • Automatic verification (i.e., FDA does not intend to conduct a Refuse to Accept review)

The voluntary eSTAR pilot program aims to improve consistency and efficiency in how the medical device industry prepares 510(k)s and how the FDA reviews these submissions. The FDA will evaluate whether the use of FDA's free eSTAR produces well-organized submissions that can be reviewed more efficiently, in comparison to submissions prepared as eCopies or with the eSubmitter application, to help promote timely access to safe, effective, and high-quality medical devices.

How is eSTAR different from eSubmitter?

eSTAR is designed and structured in a similar format as FDA's 510(k) reviewers' Smart template, and includes a collection of questions, text, logic, and prompts that guide a user through preparation of a 510(k) submission. In addition, the functionality and content of the eSTAR application are embedded within a PDF which will allow industry more flexibility when developing, viewing, and editing a 510(k).

Comparison of eSTAR and eSubmitter Qualities
Program eSubmitter eSTAR
Software eSubmitter Adobe Acrobat
Familiar Interface No Yes
Automation (for example, autofill, form generation) Yes Yes
Cost Free Free
Content Structured Similar to Reviewer's Smart Review Template Partially Completely
Standardized Submission Structure Yes Yes
Embedded Resources (for example, links, help text) Yes Yes
Guided Preparation Yes Yes
Resources and/or Databases Integrated Standards, Product Codes Standards, Product codes, Guidances
Ability to Add Comments No Yes, when saved as a static PDF
Support for Pictures and Dynamic Pop-up Text No Yes
Mobile/Mac Support (for example, iPhone, Android, iPad) No Yes
Supports Supplements and Amendments No Yes

How to prepare a 510(k) for the eSTAR Pilot Program

  1. Download either the Non-In Vitro Diagnostic eSTAR PDF or the In Vitro Diagnostic eSTAR PDF template. Be sure to save the document on your computer by right clicking the link, (or pressing "control" + clicking on a Mac) and choosing Save Link As/Download Linked File, before you open it in Adobe Acrobat Pro and begin entering in data.
    Note: This template is only used for constructing, not submitting, your 510(k) submission. The directions at the end of the template provide instructions on how to submit.
  2. Read, understand, and follow the directions in the Introduction, Key, FAQ, and Version History sections of the eSTAR PDF template.
  3. Fill in the template accordingly.

Definitions:

eCopy: An electronic copy is a submission created and submitted on a compact disc (CD), Digital Versatile Disc (DVD), or flash drive and mailed to the FDA, and which is a duplicate of the previously required paper copy sent to FDA. An eCopy is not considered an eSubmission.

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.

eSTAR (electronic Submission Template And Resource): An electronic submission template 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 510(k) submissions as eSubmissions. For simplicity, the electronic submission created with this electronic submission template is often referred to as an eSTAR.

eSubmitter: A freely available FDA software program that contains electronic submission templates, including the eSubmitter electronic submission template that was available for preparing non-IVD 510(k) eSubmissions from September 2018 through May 2021, and is no longer available for use.

How to submit a 510(k) for the eSTAR Pilot Program

If you are participating in the voluntary eSTAR pilot program, your submission should include:

  • The eSTAR PDF with embedded attachments on a CD, DVD, or USB Drive (SD cards are not accepted).
  • A printed cover letter to the Document Control Center (DCC). For the current mailing address for CDRH's Document Control Center, see eCopy Program for Medical Device Submissions.

For example, an acceptable submission package would consist of a printed cover letter accompanying a USB drive containing the eSTAR PDF.

Participants of the eSTAR pilot program do NOT need to be eCopy compliant. The eSTAR PDF does not need to be zipped and placed in a MISC FILES folder.

After you complete your eSTAR file correctly, the status message at the top will indicate "eSTAR Complete." If you submit your eSTAR file while the status message still indicates "eSTAR Incomplete," your eSTAR file will be excluded from the pilot and instead processed as an eCopy file. Because eSTAR files are, by default, not eCopy compliant, eCopy validation will likely fail, and your submission will be placed on hold until a valid eSTAR file or eCopy file is received. Please be advised that the benefits of eSTAR (for example, no RTA review) are dependent on accurate responses and FDA will verify the accuracy of your responses. Inaccurate responses, such as inaccurate responses to drop down fields enabling submitters to omit subsequent questions, may lead to an early hold in the review of your submission.

How to submit responses to requests for additional information

Indicate the “Application Sub-Type” is “Additional Information” in the first section of the eSTAR "Application/Submission Type." After you indicate this, an additional section will appear to provide responses to requests for additional information.

What are the eSTAR Pilot Program MDUFA User Fees?

510(k)s submitted as part of the voluntary eSTAR pilot program are subject to user fees. For the current User Fee amounts, please see MDUFA User Fees.

What is CDRH Review and the Review Timeline?

After the FDA receives an eSTAR-prepared 510(k) within the eSTAR Pilot Program, the FDA does not intend to conduct the RTA process. The remainder of the review will be conducted according to the FDA guidance "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" and the procedures identified in 21 CFR 807 subpart E.

Whom do I contact if I have questions?

Please contact eSubPilot@fda.hhs.gov if you:

  • Have questions regarding the pilot or eSTAR content
  • Find any malfunctions or errors in the eSTAR template
  • Would like to provide feedback about the use of eSTAR. You can also comment on the docket in the Federal Register

If you have questions regarding 510(k)s, please contact 510K_Program@fda.hhs.gov.

For general questions about medical devices, please contact the Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, 800-638-2041, or 301-796-7100.

Resources

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