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CPC Comments to FDA Draft Guidance on Design Considerations for Devices Intended for Home Use

The CPC’s comments addressed five issues:

  • Clarity is needed regarding the reviewing roles of the different Centers and Divisions, and how the various guidance documents addressing human factors will be applied.
  • Application of the Draft Guidance to home use combination products containing a drug constituent part should be clarified.
  • The guidance should clarify in what situations human factor testing may be subject to IDE requirements.
  • User checklists that include only the most critical steps necessary to ensure safe use of combination products should be implemented as part of the draft guidance.
  • FDA should clarify what it considers to be a “device design flaw” and recognize that labeling might mitigate some risks.