CPC Comments on FDA Draft Guidance on Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA or PMA

The CPC’s comments recommended changes to the guidance document that would address the following issues:

• Whether the guidance only addresses the type of submission required if a manufacturer determines that a submission is necessary, or if it also addresses how manufacturers should evaluate whether a submission is required.
• The types of submissions required when a change is made to a device constituent part that would be subject to 510(k) rules if it were a stand-alone device.
• The need for new guidance on how to apply current regulations and guidance to determine whether a postmarket change to a constituent part requires a postmarket submission.