Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Our company is moving to a new location. We manufacture and distribute medical devices. For a  FDA Class II device with special controls, will the FDA require an onsite inspection prior to allowing distribution of the products manufactured at the new site? If so, does anyone have an experience with the timelines from notification of site relocation to inspection date?

Hello Anon,

No there is no "pre-inspection" for movement of manufacturing site for a Class II device.  When a Medical Device Manufacturer registers their establishment with the US FDA, once on this database they are subject to an inspection, at any time, by the FDA - for any class of device.  When you change the manufacturing site and you are the legal manufacturer (same address) then this would be reflected in the Establishment Registration listing.  Will it trigger an inspection at some point in time?  Maybe.  It depends on when your last inspection was, type of device, and the FDA's inspection database (which is of course not public).  Internally within your quality management system you want to document the change, make all the changes, implement a quality plan for the manufacturing site move, and ensure all the QSR/GMP activities are completed, i.e. validations, process review, etc.  Then if and when FDA performs an inspection, this may be information they would review.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 04-Aug-2020 18:30
From: Anonymous Member
Subject: FDA Inspections for site relocation

This message was posted by a user wishing to remain anonymous

Our company is moving to a new location. We manufacture and distribute medical devices. For a  FDA Class II device with special controls, will the FDA require an onsite inspection prior to allowing distribution of the products manufactured at the new site? If so, does anyone have an experience with the timelines from notification of site relocation to inspection date?

For Class II devices there is no pre-approval inspection required to begin manufacturing at a new facility in the way that there is for a PMA or HDE device.  For a Class III PMA device or an HDE device, you must submit a Site Change Supplement to the FDA and receive approval before you can begin distributing product manufactured at a new facility.  This review and approval process may involve a pre-approval inspection of the new facility.  The FDA has a guidance document detailing when a Site Change Supplement is needed for PMA (180-days) and HDE devices (75-days).  As is noted in other responses, there is no requirement for an inspection prior to manufacturing and distributing product for a Class I or II device.

------------------------------
Matthew Krueger RAC
Senior Consultant
Laurel MD
United States
------------------------------

Original Message:
Sent: 04-Aug-2020 18:30
From: Anonymous Member
Subject: FDA Inspections for site relocation

This message was posted by a user wishing to remain anonymous

Our company is moving to a new location. We manufacture and distribute medical devices. For a  FDA Class II device with special controls, will the FDA require an onsite inspection prior to allowing distribution of the products manufactured at the new site? If so, does anyone have an experience with the timelines from notification of site relocation to inspection date?