FDA has kicked off a new voluntary electronic submission program for 510(k)s. The “electronic Submission Template And Resource (eSTAR) Pilot Program” is a template that guides 510(k) submitters through the process of preparing a comprehensive medical device 510(k) submission. The free template contains:
Automation (such as form construction and autofilling).
Content and structure that is complementary to CDRH internal review templates.
Integration of multiple resources (such as guidances and databases).
Guided construction for each submission section.
Automatic verification (FDA does not intend to conduct a “Refuse to Accept” review for the pilot).
FDA is soliciting participation from 510(k) submitters. It began accepting statements of interest for participation in the pilot program in February 2020. The agency will select up to nine participants that provide a holistic representation of the medical device industry and that meet the selection criteria, which is outlined in the Federal Register Notice. To take part in the pilot, manufacturers must meet all of the following criteria:
You must be granted acceptance into the pilot.
You must plan to submit a Traditional, Special, or Abbreviated 510(k) for a medical device (not a combination product) using eSTAR within three months of acceptance.
You must plan to submit at least one 510(k) for a device that contacts body tissue and includes software.
You must be willing to provide feedback on eSTAR as outlined in section I.C. of the Federal Register notice.
The eSTAR must be complete, as indicated by the message at the top of the eSTAR PDF.
The eSTAR program is different from FDA’s existing eSubmitter. According to FDA, “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 guides 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).”
After the FDA receives an eSTAR-prepared 510(k), FDA does not intend to conduct its “Refuse to Accept” process. The remainder of the review will be conducted according to the FDA guidance ‘The 510(k) Program: Evaluating Substantial Equivalence in Premarket’ and the procedures identified in 21 CFR 807 subpart E.”
The agency is also requesting feedback to targeted questions to assess the pilot program.
Editor and Director of Medical Content