CPC Comments on FDA’s Draft Guidance on Use of International Standard ISO-10993 “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing”

The CPC submitted comments for FDA Draft Guidance on the use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, requesting that FDA provide additional guidance on the following issues:

1. Considerations that manufacturers of combination products should analyze to determine the proper biocompatibility testing required to support a combination product marketing submission
2. Whether the principles set forth in the Draft Guidance apply to all device constituent parts of combination products, regardless of a particular combination product’s primary mode of action