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Today, the U.S. Food and Drug Administration (FDA) issued this draft guidance: Electronic Submission Template for Medical Device De Novo Requests. This draft guidance builds on the guidance Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act that specified which medical device submissions will be required to be submitted only in electronic format and which submissions are exempt from electronic format requirements. This guidance describes resources to support electronic submission of De Novo requests to the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).
Facts about this draft guidance:
- Introduces the current electronic tool and requested submission content, specifically the electronic Submission Template And Resource (eSTAR), for preparing De Novo requests.
- Describes significant terminology associated with electronic submissions.
- Explains current electronic submission template structure, format, and use.
- Explains electronic submission template waivers, exemptions, and timing.
This guidance represents one of several steps in meeting the FDA’s commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process.
Note: This guidance is not for implementation at this time.
Submit comments on this draft guidance
Beginning on September 29, 2023, submit comments under docket number FDA-2023-D-3788 at www.Regulations.gov within 60 days to ensure the FDA considers comments on this draft guidance before it begins work on the final version of the guidance.
Questions?
If you have questions about this draft guidance, contact the Division of Industry and Consumer Education.
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