📄FDA's Draft Guidance for Electronic Submission of Medical Device Q-Submissions
Electronic Submission Template for Medical Device Q-Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Electronic Submission Template for Medical Device Q-Submissions." FDA is issuing this draft guidance to introduce submitters of certain Q-Submissions (Q-Subs), specifically Pre-Submissions (Pre-subs) to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER), to the current resources and associated content developed and made publicly available to support Pre-Sub electronic submissions to FDA. This draft guidance, when finalized, is intended to represent one of several steps in meeting FDA's commitment to the development of electronic submission templates to serve as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. This draft guidance is not final nor is it for implementation at this time.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The draft guidance on the electronic submission template for medical device Q-Submissions outlines new compliance requirements for industry stakeholders in the medical device sector, particularly for Pre-Submissions. It indicates a shift towards electronic submissions, creating a need for businesses to adapt their submission practices, which may incur costs or savings.