125 - Unpacking the Quality Management System Regulation(QMSR) Final Rule with Subhi Saadeh
On this episode, I do an active reading to begin to unpack the Quality Management System Regulations(QMSR) Final Rule that was issued by FDA in early February 2024.
0:00 Introduction
05:09 Initial Reactions to the idea of the QMSR
06:57 History of the Device cGMP's, QSR, and QMSR
11:52 What's changing in 21 CFR 820?
24:59 What's changing in 21 CFR 4 and Combination Products
33:20 Comments Review and Final Thoughts
Links:
- QMSR Final Rule Amendments: https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments
- QMSR Final Rule FAQ: https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked
- 21 CFR 820: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820?toc=1
- 21 CFR 4 (Changes Introduced): https://www.ecfr.gov/compare/2024-02-02/to/2024-02-01/title-21/chapter-I/subchapter-A/part-4/subpart-A
- Device cGMP's 21 CFR 820 (1978): https://archives.federalregister.gov/issue_slice/1978/7/21/31497-31571.pdf#page=12
- Reserved Definition: https://www.archives.gov/federal-register/cfr/about.html#:~:text=An%20agency%20uses%20%22%5BReserved%5D,a%20printing%20or%20computer%20error.
- ANSI View Only Copy of ISO13485 (No Cost): https://ibr.ansi.org/Standards/iso1.aspx
Subhi Saadeh is a Quality Professional and host of the Combinate Podcast. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.