FDA's Draft Template Eases Medical Device Question Submissions
Published Date: 5/29/2025
Notice
Summary
The FDA just shared a draft guide to help medical device makers send their Pre-Submission requests electronically using a new template. This change aims to make submissions easier and faster to review, but it’s not official yet, so no need to rush. If you work with medical devices, keep an eye out for when this guide becomes final—it could save you time and hassle!
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Draft electronic Pre-Sub template
The FDA released a draft guidance introducing an electronic submission template for certain Q-Submissions, specifically Pre-Submissions (Pre-subs) to the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). The template is intended to help industry improve submission consistency and enhance efficiency in the review process.
Draft guidance — not yet binding
The FDA states the guidance is draft, not final, and not for implementation at this time. If you submit Pre-Submissions to CDRH or CBER, you do not need to change your processes yet or comply with this draft guidance.
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