# 2025-19947: FDA Drafts Guidance on Quality Management for Device Submissions

2025-19947, Quality Management System Information for Certain Premarket Submission Reviews; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-11-17, effective 2026-02-02 (as of 2026-06-08).

- Canonical: https://policyrisk.com/federal-register/2025-19947
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-19947
- Title: Quality Management System Information for Certain Premarket Submission Reviews; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 51374
- Published: 2025-11-17
- Effective: 2026-02-02
- Comments close: 2026-01-16
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-08

## In one line

FDA Drafts Guidance on Quality Management for Device Submissions

## 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!

## Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Quality Management System Information for Certain Premarket Submission Reviews." The medical device current good manufacturing practice (CGMP) requirements, previously in the quality system regulation (QS regulation) and now the quality management system regulation (QMSR), have been amended effective February 2, 2026, to align more closely with the international consensus standard for devices by incorporating by reference an international standard specific for device quality management systems. This draft guidance document is intended to assist FDA staff and medical device manufacturers in understanding FDA expectations about preparing and maintaining a Quality Management System (QMS) and providing the information required to be included in certain marketing submissions regarding a QMS, in line with the QMSR. This draft guidance is not final nor is it for implementation at this time.

## Effects PRIA read

- Medical device QMS info required in submissions: cost, medium. 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 comp…
- Draft guidance adds no new PRA collections: benefit, low. 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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## Sources
- [2025-19947 on federalregister.gov](https://www.federalregister.gov/documents/2025/11/17/2025-19947/quality-management-system-information-for-certain-premarket-submission-reviews-draft-guidance-for)
- [2025-19947 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-11-17/pdf/2025-19947.pdf)

## Related
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Source: PRIA, https://policyrisk.com/federal-register/2025-19947 (as of 2026-06-08).