The U.S. Food and Drug Administration (FDA) has issued a final guidance intended to clarify the responsibilities of medical device developers when changing manufacturing sites for previously approved devices.
Issued earlier this week, the final guidance “Manufacturing Site Change Supplements: Content and Submission” includes information to help manufacturers understand the specific circumstances in which a site change requires the filing of a premarket approval application (PMA) supplement with the FDA. Specifically, the guidance explains:
- What constitutes a manufacturing site change, and when a manufacturer should submit a PMA supplement;
- What documentation should be submitted to the Agency in a site change supplement; and
- The factors that the FDA will consider when determining whether to conduct an establishment inspection prior to approval of a site change supplement.
As always, FDA guidance documents are intended to present the Agency’s current thinking in connection with a specific topic, and do not establish legally enforceable responsibilities.