FDA Drafts Guidance on Quality Management for Device Submissions
Published Date: 11/17/2025
Notice
Summary
The FDA is sharing a draft guide to help medical device makers and staff understand new rules about Quality Management Systems starting February 2, 2026. These changes align U.S. rules with global standards, making it easier to prepare and share quality info in device marketing submissions. If you’re in the medical device world, get ready to update your paperwork and share your thoughts by January 16, 2026!
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Medical device QMS info required in submissions
If you make medical devices, the QMS (quality management system) rules were amended effective February 2, 2026, to incorporate ISO 13485:2016. The FDA’s draft guidance explains what QMS information must be prepared, maintained, and included in certain marketing submissions so FDA can determine compliance with the new QMS regulation.
Draft guidance adds no new PRA collections
The draft guidance says it contains no new collection of information under the Paperwork Reduction Act. It refers to previously approved FDA collections, including 21 CFR part 820 (CGMP; Quality System) with OMB control number 0910-0073 and other listed OMB approvals.
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