The New QMSR, the CGMPs for Devices

Consists of:

• ISO 13485:2016, included in its entirety by reference in  revised 21 CFR 820;
• ISO 9000:2015, clause 3 (definitions), included by by reference in 820;
• "Read only" copies of both the above are available on the web - addresses provided in the QMSR;
• Most of previous 21 CFR 820, including all of C-O subparts, have been removed and reserved;
• New Subparts A and B comprise the rest of the QMSR, 21 CFR 820.
• The FDA has stated they are not changing the scope of the QSR in the new QMSR.  So read ISO 13485 as if it includes all of the old QSR in general.  Areas of special emphasis are in the new QMSR / 820 subparts (to address the pertinent requirements of the US' FD&C Act not fully addressed in ISO 13485). 
• Basic changes are in some changes to definitions, the elimination of FDA's past policy of not reviewing a company's internal audits, quality reviews, vendor audits, increased emphasis on labeling beyond ISO 13485.  
• ISO 13485's emphasis on risk management to be ISO 14971's definition: to patient, to user/clinician, to use environment plus compliance risk.
• Corresponding changes to QSIT and applicable guidance documents and 21 CFR 4, Combination Products, will be made.
• Until a company completes the change, they will be required to follow and be inspected to the the old QSR. 
• FDA has settled on a two year transition period, until 02/02/2026.

The change will require a rewrite of a company's Quality Manual and QMS SOPs, primarily in terminology and reference citations, not in the specific functions addressed. Training in the same will also be necessary.

      -- 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

      -- jel@jelincoln.com

Eliminated a typo on Subpart B and added reference to the US' Food, Drug and Cosmetic (FD&C Act). - JEL 05/01/2024

To clarify, the FDA has stated that it will not inspect to the new QMSR until the two year implementation period has ended, Feb 02, 2026. - JEL 10/08/2024