Regulatory Open Forum

Hello,

I had a query about the Quality Management System inspection by the FDA. Once a medical device receives a 510(k) clearance but Establishment Registration & Device Listing has not been done as the company does not plan to manufacture the device, can the FDA inspect/audit the Quality Management System? or is an inspection done only post-Establishment Registration & Device Listing?

Thanks a lot!

FDA ultimately by law (sec. 704 of the FD&C Act) has legal authority to inspect a device establishment after 510(k) clearance yet before the establishment has registered even if no manufacturing is happening.  But in practice, FDA doesn't generally do that.  Instead, FDA generally triggers and schedules its 510(k)-device inspections based on the the establishments that have identified themselves and their triggering operations (e.g., click here for a list of those triggering operations) to FDA via the establishment registration system after 510(k) clearance.

Indeed, when promulgating the establishment registration regulations (21 CFR Part 807), FDA literally said that FDA requires establishment registration so that FDA can be aware of the establishments for the specific purposes of inspection.  FDA requires registration to happen within 30 days of starting an aforesaid triggering operation.  If no such triggering operation is yet happening, then no such registration is yet required.

And though outside the scope of your question at the moment, I'll conclude by mentioning that once firms are identified to FDA via establishment registration, then FDA uses various risk-based scheduling principles to decide which firms will be scheduled for inspection.

Hello,

I had a query about the Quality Management System inspection by the FDA. Once a medical device receives a 510(k) clearance but Establishment Registration & Device Listing has not been done as the company does not plan to manufacture the device, can the FDA inspect/audit the Quality Management System? or is an inspection done only post-Establishment Registration & Device Listing?

Thanks a lot!