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FDA Posts De Novo Final Rule, Electronic Submissions Draft Guidance

The FDA’s device center resumed work recently on its regulatory to-do list with a final rule for applications for de novo devices and a draft guidance for electronic submissions. While the updates are much-needed additions to the agency’s regulatory agenda, the list for fiscal year 2021 makes clear that more items were left undone than were completed, such as the absence of a final guidance for clinical decision support software. 

The FDA’s Center for Devices and Radiological Health (CDRH) had indicated that the final rule for de novo filings would help the agency and industry clean up some de novo premarket filings that were frequently incomplete and/or poorly organized. The final rule carried over the draft rule’s discussion of facility inspections that would be conducted prior to the grant of the de novo petition. The agency cited several justifications for such an inspection, such as allowing the agency to ensure that a novel sterilization method is achieving the needed level of sterility. 

One of the features of the draft rule was that the FDA had proposed to require the sponsor to submit all information regarding any potential risks that are “known or reasonably known” by the manufacturer. After some back-and-forth with stakeholders, the FDA settled on language which states that filings should encompass all information “known to or that reasonably should be known to the requester.” In addition to the need to ensure that the sponsor conducts an adequate search for any information related to risk, fulfillment of this requirement should reduce the amount of time needed to process the filing. 

The de novo process can be used to provide a class I risk designation for a novel device type, and one comment to the draft was that the agency should consequently adjust its expectations for the standard for valid scientific. The FDA’s position is that the term “valid scientific evidence” already offers enough flexibility to meet the demands of all manufacturers and scenarios.

Electronic submissions for 510(k)s to become mandatory 

The guidance for electronic submissions serves as a template for e-submissions for 510(k) applications, although e-submission guidances will emerge for PMA and de novo filings as well. The Food and Drug Administration Reauthorization Act (FDARA) of 2017 authorized the FDA to make electronic submissions compulsory as a method of facilitating the agency’s reviews. The text of FDARA had mandated that the FDA issue draft guidance no later than Oct. 1, 2019, and a final guidance a year after that.


The agency stood up a pilot program for elevating the quality of 510(k) reviews in 2018 as a first step in the transition to electronic-only submissions for abbreviated and traditional 510(k)s. In February 2020, the next phase in the transition, the eSTAR pilot program, was ramped up, which provided an electronic template with autofill features to ease the filing experience for industry. As of May 30, 2021, the 2018 review quality program is no longer available, leaving the eSTAR mechanism the only existing method for electronic filings of 510(k)s. 

The eSTAR filing mechanism is not subject to the refuse-to-accept policy for 510(k)s, although a technical screening process will be applied. That process should be completed within 15 days of receipt of the filing, assuming the applicant has paid the associated user fee. Any incomplete eSTAR submissions will be subjected to a 180-day hold, during which the applicant can file a completed version. If the sponsor has not done so by 180 days, the FDA will close the filing and deem it to be a withdrawn submission. The agency said it may offer a one-year transition period for applications after the final guidance is made available.


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