FDA updates definitions: what constitutes a manufacturing site change?

The new guidance​ will replace an earlier document, “Likelihood of Facilities Inspections When Modifying Devices Subject to Premarket Approval,” which was issued August 5, 1999. However, this guidance was never finalized. Today, based on industry feedback – and after gaining more than 15 years of experience – the FDA has made substantial revisions to the original guidance.

"Because the 1999 draft guidance was never finalized and in light of feedback the agency has received over the last several years, the draft guidance on manufacturing site changes was issued to solicit new comments that can be considered in an effort to finalize the document​," an FDA spokesperson told OutSourcing-Pharma.com.

The updated document outlines FDA recommended steps to help determine whether a PMA supplement should be submitted in the event of a manufacturing site change (including a change to the processing, packaging, or sterilization site).

Additionally, it discusses general factors the FDA may use to determine whether a preapproval inspection is necessary before approval of the PMA supplement.

The document outlines several types of manufacturing site changes, including moving manufacturing, processing, or packaging activities to a contract manufacturer not approved as part of the original PMA.

According to the FDA, “This guidance should help manufacturers manage the timeframes associated with implementing the changes in the manufacturing site and any processes, methods, procedures, qualifications, and validations​.”

For a complete list of site change types, view Manufacturing Site Change Supplements: Content and Submission​.

The administration will be accepting comments until January 19, 2016.