BIO Comments on FDA Draft Guidance: Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only

The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments regarding the Food and Drug Administration’s (“FDA’s”) draft guidance document entitled Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions (“the Draft Guidance”).

With regard to the Draft Guidance, BIO is concerned that the definition of “research use” is inappropriately narrow.  Further, BIO believes that FDA’s interpretation of “intended use” in the Draft Guidance is inconsistent with applicable law, and goes beyond FDA’s historical interpretation of “intended use.”  Finally, BIO urges FDA to take a cautious and measured approach to enforcement under the provisions of the Draft Guidance.  Some stakeholders may need to prepare and submit regulatory submissions based on this interpretation, and it is critical that FDA actions do not inadvertently inhibit innovative research activities that could fall under the purview of the Draft Guidance.