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Author: Silas Minnick, Senior Quality Engineering Consultant

On September 29, 2021, the FDA issued a draft guidance regarding a new Electronic Submission Template for Medical Device 510(k) Submissions.

The draft guidance is one of several steps the FDA is taking to increase 510(k) reviewing efficiency through a more uniform and consistent submission process. The FDA plans to accomplish this by developing guided submission preparation tools, including the new eSTAR template.

This draft guidance, when finalized, will contain both binding and nonbinding provisions.

What is eSTAR?

Essentially, eSTAR is an alternative to eCopy and eSubmitter, the current tools used by companies to prepare 510(k) premarket notifications. Reviewers created the user-friendly eSTAR tool to guide people through the complex 510(k) submission process.

The eSTAR is an electronic submission template built within a structured, dynamic PDF that guides a user through the construction of an eSubmission in keeping with the FDA’s intention to make the 510(k) submission process easier and more efficient.

Highlights of the eSTAR template include:

  1. Built-in workflows that create summaries of all sterilization, validation, and biocompatibility testing provided.
  2. Checklists to ensure you have all required software and firmware verification and validation documentation.
  3. Each section of the 510(k) submission process includes hyperlinks to the most recent FDA guidance documents.
  4. The ability to include non-PDF files up to 1GB in size.
  5. An automatic verification system that alerts you when each section of the 510(k) is complete.
Does your company have to use the eSTAR template?

If applicable for your medical device, you can use the eSTAR template for 510(k) submissions, but it is not a requirement. As of this writing, you may continue to use the current 510(k) submission method if you prefer.

If you choose to utilize eSTAR, you can find a thorough outline of the eSTAR template in Table 1 of the draft guidance.

One important item to note: Using the eSTAR template eliminates the risk of a Refuse to Accept rejection.

What’s next?

By September 30, 2022, the FDA will announce the deadline by which all 510(k) submissions must be completed electronically. Once the FDA announces a date, we believe there will be a transition period of a minimum of one year before electronic submissions are mandatory.

The September 29, 2021 draft guidance will also be updated and finalized to reflect that specific date and outline the particular electronic format(s) required for 510(k) submissions.

Upon finalization, 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. 115-522) will also be affected. The draft guidance will provide further standards for the submission by electronic format, a timetable for establishing these standards, and criteria for waivers and exemptions from the requirements.

Lean Into Our FDA 510(k) Expertise

Not sure how to approach this new guidance on 510(k) submissions? Partnering with our knowledgeable medical device regulatory consulting experts will make the process easier.

Our deep FDA consulting expertise helps us guide our clients through the FDA landscape, including 510(k) submissions, to ensure the success of their medical devices.

Let’s get the regulatory conversation started.