Overview
In August 2024, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced that starting in October 2025, medical device manufacturers must use the eSTAR (Electronic Submission Template and Resource) model for submitting new registration applications.
This updated guidance supersedes a draft issued in September 2023 and incorporates several revisions, including the establishment of a mandatory effective date for the new requirements.
Introduction
The eSTAR program is an interactive PDF template designed to facilitate the electronic submission of applications by industry. Launched in February 2020 for the 510(k) process, it was developed as part of the FDA’s commitments under the previous Medical Device User Fee Amendments (MDUFA IV) program.
The FDA says it will conduct a technical review within 15 calendar days of receiving the submission and payment of the user fee.
The guidance explains that “if the eSTAR is not complete at the time of submission, the FDA will notify the submitter by e-mail, identifying the missing information, and the De Novo application will be placed on hold.
If a revised eSTAR is not received within 180 days from the date of the technical screening deficiency notification, the FDA will consider the De Novo application withdrawn, and the submission will be closed in the system.”
The guidance also addresses exemptions and waivers for electronic submissions, specifying that the following types of De Novo submissions are exempt from the electronic requirements: interactive review responses, appeals and supervisory review requests, and substantive summary requests. The FDA stated that it has not identified any specific circumstances that would warrant a request for an exemption from the electronic submission requirements for De Novo applications.
The guidance details the information that:
- Included in the submission should be a cover letter
- Data from the applicant,
- Information on any pre-submission correspondence
- A list of consensus standards followed by the device
- Description of the device
- Proposed indications for use
- Classification of the device, its benefits, risks and mitigation measures
- Device labeling
- Information on its reprocessing.
Guidelines for consideration
The changes from the draft guidance, according to an FDA announcement, include “clarification of the use of technical screening during acceptance review and the inclusion of the date on which the use of eSTAR for De Novo applications will become obligatory.”
Additionally, the final guidance adds new text that specifies how the FDA will review De Novo applications submitted in electronic format. It states that, “in evaluating the criteria described, FDA staff should also consider whether the De Novo application involves devices of more than one type. In certain circumstances, it may be appropriate for FDA to review multiple devices in a single marketing submission.”
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References
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About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.