FDA issues draft guidance on electronic 510(k) submissions

Regulatory NewsRegulatory News | 28 September 2021 |  By 

The US Food and Drug Administration (FDA) on Tuesday issued a draft guidance to assist sponsors in using an electronic template for submitting a premarket notification 510(k).
In the draft guidance, FDA said it will accept the electronic Submission Template and Resource (eSTAR) template for applications to the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). 
The guidance implements section 745(A)(b) of the Food and Drug and Cosmetic Act (FD&C Act), as amended by section 207 of the FDA Reauthorization Act of 2017 (FDARA), which required FDA to transition to electronic formats for all medical device applications. On 30 September 2022, FDA will specify a date for when they will require 510(k) electronic submissions. In July 2020, FDA issued a final guidance that laid out the framework for electronic submissions for medical devices. (RELATED: Electronic device submissions addressed in FDA guidance, Regulatory Focus, 15 July 2020).
In the 2020 guidance, FDA said it would be issuing more specifics about electronic submissions for individual device types such as 510(k)s, de novo devices, premarket approval applications (PMAS), modular PMAs, product development protocols (PDPs) and humanitarian device exemptions (HDEs).
The draft guidance said that eSTAR is “highly automated, includes integrated databases (e.g., FDA product codes, FDA-recognized voluntary consensus standards), and includes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.”
The program is also structured so that submitters can enter content and have it be assembled in the 510(k) submission format; it also “closely follows” the “SMART” 510(k) review memo template used by CDRH reviewers.
This template should be used to transmit the cover letter, the submitter information, information on previous submissions of the same device, the description of the device, proposed indications for use, the predicate device and substantial equivalence, the device’s labeling, and information on methods used to sterilize the product, among other required components of the submission.
Once the draft guidance has been finalized, FDA will require electronic submissions for all 510(k) submissions and subsequent submissions to an original submission, including amendments and supplements. A 510(k) submission that is not in this format will not be accepted unless it has been exempted from being submitted electronically or the developer has received a waiver.
In earlier comments on FDA’s electronic submissions guidance, the Advanced Medical Technology Association (AdvaMed) urged FDA to provide a “reasonable transition time” to phase in the electronic filing requirements in order to allow industry enough time to implement and validate their submissions, suggesting 18 months as a reasonable period.
FDA announced in February 2020 it would pilot the interactive, PDF-based 510(k) eSTAR template as the next step in transitioning to 510(k) submissions based on an electronic format.  (RELATED: FDA to Pilot Interactive 510(k) Template, Regulatory Focus 26 February 2020)
In October 2020, FDA announced that it would accept participants to test the system. (RELATED:  Volunteers sought for CDRH cloud submission pilot, Regulatory Focus 8 October 2020)
The deadline for submitting comments is 28 November.
FDA draft guidance
AdvaMed comments  


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you