FDA Town Hall – Quality Management System Regulation: Risk and Design and Development,   01/14/26, Wednesday, 2:00 PM ET,  US FDA, ~1 hour

I just attended an FDA Teams audio presentation on the new QMSR to be implemented on February 02, 2026, by all Medical Device Companies selling product in the US.  

Some key takeaways:

-  Risk management is an important part of the new QMSR / ISO 13485: 3.17, 3.18, 4.1.2(b), 7.1, 7.3, and     7.4;

-  Design and Development ( the old Design Control) is an important component of risk management;

-  The FDA expects that the design review team(s) have independence for decision making;

-  ISO 14971 or a similar risk management system should form the basis of the QMS / device risk       

   management activities, especially pertaining to QA/QC, Production and Purchasing; 

   Note that harm (to patient / people is the focus of FDA's/ISO 14971's requirements, not financial /  

   scheduling / business risks; 

-  Design control is not retroactive for devices;  only a requirement for devices designed or changed since 

   October 1997 (when 820.30 Design Control was implemented);

-  Changes to a device can be documented in the DHF or under the company's CGMP change control   

   system;

-  The DHF or applicable product documents (and risk management documents) should be reviewed 

   periodically or when a new risk is   

   determined, and updated / addressed accordingly;

-  Ditto the risk management elements of the QMS (and the Device Risk Management file);

-  The FDA does not expect companies to change existing historical documents (e.g., DHFs, archived  

   documents) to reference the new changes, references, terminology.    

One key point that was not addressed was the Final Rule / Preamble emphasis that the QMSR is not intended to, nor does not substantially change, the QMS of the old QSR, that ISO 13485 meets the basic requirements of the old 21 CFR 820, except for a change in references (generally from 820 to ISO 13485),  some terminology changes, and a few legal requirements unique to the USA as required in the FD and C Act, under which the FDA acts. 

A transcript of the meeting should be available on fda.gov in approximately 2 weeks.  

-  jel@jelincoln.com 01/14/2026