The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) last Friday announced that effective next October 2025, medical device manufacturers will have to use the electronic Submission Resource and Resource (eSTAR) template for submitting de novo applications.
The guidance replaces a draft version issued in September 2023 and includes some revisions, including the addition of a mandatory date for when these requirements will go into effect.
The eSTAR program is an interactive PDF-based template to assist industry in submitting applications electronically; it was launched in February 2020 for 501(k)s as part of its commitments under the previous Medical Device User Fee Amendments (MDUFA IV) program.
The eSTAR program was expanded to include devices submitting under the de novo pathway in December 2021.
The guidance discusses the information that should be included in the submission, and states that the de novo electronic submission should include a cover letter; applicant information; information on any presubmission correspondence; a list of consensus standards to which the device adheres; a device description; proposed indications for use; the device’s classification; its benefits, risk and mitigation measures; the device’s labeling; and information on how the device is to be reprocessed.
FDA states that it will conduct a technical screening process within 15 calendar days of receiving the submission and the user fee has been paid. The guidance states that “if the eSTAR is not complete when submitted, FDA will notify the submitter via email and identify the incomplete information, and the De Novo will be placed on hold. If a replacement eSTAR is not received within 180 days of the date of technical screening deficiency notification, FDA will consider the De Novo to be withdrawn and the submission will be closed in the system.”
The guidance also discusses exemptions and waivers from electronic submissions and notes that the following type of de novo submissions will be exempt from the electronic filings: interactive review responses, appeals and requests for supervisory review, and substantive summary requests. FDA stated that it has not identified any specific circumstances warranting a waiver request for the de novo electronic submission requirements.
According to an FDA announcement, changes from the draft guidance include “clarification of the use of technical screening during acceptance review and inclusion of the date when the use of eSTAR for De Novo Requests will become mandatory.”
The final guidance adds new text specifying how FDA will review de novo requests submitted in electronic format. It states that “in evaluating the criterion described in 21 CFR 860.230(c)(1)(iv) FDA staff should also consider if the De Novo request is for devices of more than one type. It may be appropriate for FDA to review multiple devices in a single marketing submission under certain circumstances.”
FDA states that leading up to the effective date next October, there will be a one-year transition period where these submissions can continue to be submitted voluntarily.
FDA rejected a request from the Advanced Medical Technology Association (ADvaMed) to grant waivers in certain circumstances and “unique situations.”
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