Urgent Reminder!

The FDA deadline for the change from Medical Device QSR to the new QMSR is fast approaching -  February 02, 2026!  FDA CGMP Compliance Inspections are currently being conducted to the old QSR/QSIT (old 21 CFR 820) up to February 02, 2026, but after that date will be conducted to the new QMSR - the new 820, Subparts A and B, ISO 13485 in its entirety, and Clause 3 of ISO 9000.

This requires that a company's Quality Manual, QMS SOPs, and training be updated to the new QMSR and be completed with all QMS systems ready to go live on February 02, 2026.

We are rewriting QMs and SOPs for clients, to conform to these new requirements and would be happy to assist your company in doing so.

- JEL, jel@jelincoln.com 

In it's Preamble to the new 21 CFR 820, the FDA has stated that the switch should cause no discernable change in your actual QMS, but primarily in your SOP references (to the ISO 13485, rather than to the old 820) and in terminology (per ISO 9000, not 9001, Clause 3).  If you determine that you think a change is required in your QMS as to how you perform a task, revisit your thinking! - JEL 11/30/2025