Pivotal Device Clinical Trial Guidance Comment

Comment letter submitted by the CPC offering a response to the Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff; Design Considerations for Pivotal Clinical Investigations for Medical Devices (“Draft Guidance”). CPC’s comments addressed:

• The failure to including labeling for combination products in the guidance document.
• The need for FDA to provide details regarding the applicability of drug or device regulatory principles to clinical trials involving combination products.
• The need for clarification of jurisdictional issues relating to clinical trials