CDRH and CBER have issued a new guidance clarifying the definitions of changes to a manufacturing site for medical devices and giving clearer instructions on what type of supplement to file for each type of change. The agency’s thinking on changes to device manufacturing sites was previously established in a letter in 1996 and updated with a draft guidance in 1999 that was never finalized. The new guidance, “Manufacturing Site Change Supplements: Content and Submission”, will replace both of these documents as the current agency thinking on the topic.

Supplements to the approved submission are required when the changes to the site affect the safety and effectiveness of the device. Changes that don’t affect device safety and effectiveness may be filed as a 30-day notice. Manufacturing changes to device components that are not critical to device function, operation, or specifications may be filed with the device’s Annual Report. The best features of the guidance are the definitions list, the table showing the type of manufacturing site changes and the agency’s recommendations for supplemental filing, and the examples provided for each type of site change. We can always applaud any new guidance that spells out the agency position in such clear detail.

Text Copyright © 2019 Katrina Rogers