CPC Submits Comments on FDA’s Policy to Be Proposed Regarding Premarket Notification Requirements for Modifications to Legally Marketed Devices

The CPC submitted comments on FDA’s Report to Congress entitled Report on FDA’s Policy to be Proposed Regarding Premarket Notification Requirements for Modifications to Legally Marketed Devices, requesting that FDA take the following actions to clarify the application of any resulting guidance to combination products:

• Expressly declare the applicability of the guidance to
  • combination products marketed pursuant to 510(k) clearance and
  • class II equivalent device constituent parts.
• Include specific examples involving modifications to combination products to which the guidance applies.