FDA Draft Guidance: Manufacturing Site Change Supplements, 10/15

$0.00

The CDRH and CBER branches of the US FDA drafted Manufacturing Site Change Supplements: Content and Submission to help industry determine when a manufacturing site change requires submission of a PMA (Premarket Approval) site change supplement. The guidance is also intended to help industry predict when an FDA pre-approval inspection is likely to be required for a manufacturing site change. This guidance is meant to help firms manage the timeframes for changes in manufacturing sites and associate changes to processes, methods, procedures, qualifications, and validations.

There are two topics specific to computers and software:

• Section III Part A (Definitions) Part A includes software in the list of medical device components. Section IV Part A (Site Change Supplement vs. 30-Day Notice) requires a 30-Day Notice for 3 categories of changes to the manufacturing of critical components: (1) change to out-sourcing (2) changing the outsourcing provider (3) change to in-sourcing
• Section IV Part B (Site Change Supplement Contents) recommends including the validation or revalidation plan for software used as part of the production or quality system