My response to my recent "Device Changes and the 51(k)" webinar question from an attendee:

Ques:  If you are transferring production from a current CMO to a brand-new internal facility with in-house process, does that require a full new 510k submission?

 

Ans:  Same as before.  Moves of production locations/personnel, changes in production equipment, etc., can generally be addressed by specific-to-the-move (not just routine) validation, showing any changes in equipment, personnel, location, and similar, had no negative effect on the outgoing product, i.e., it still met specification. 

 

This is in line with my comments during the webinar on the FDA's default to your QMS (in this case production validation's strong positive results) negating the need for a new 510(k) - see related discussion on the role of your QMS in negating a need for a new 510(k), in the referenced Guidance Documents. 

 

The key issue is no negative change in "safety and efficacy" of the product. Generally this can still hold true even if you make some major changes to the type of equipment / processes used, all well documented / explained, backed up by any Device Risk Management File (ISO 14971) updates, all under change control of course.

-- jel@jelincoln.com  10/15/2025