FDA Issues Final Guidance on Manufacturing Site Changes

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.

Read the complete text of the FDA’s final guidance on manufacturing site changes.

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