CPC Submits Comments to NIH on Clinical Trials Proposed Rule

The CPC submitted comments to NIH’s Proposed Rule – Clinical Trials Registration and Results Submission, recommending that:

• Applicable clinical trials involving combination products with a device PMOA should be considered “applicable device clinical trials” not “applicable drug clinical trials”
• NIH should update the definitions of “FDA-regulated drug” and “FDA-regulated device” to include combination products with appropriate PMOAs
• NIH should confirm that even if one constituent part of a combination product is approved, licensed or cleared independently, a combination product as a whole will be considered unapproved, unlicensed or uncleared by FDA so long as any constituent part remains unapproved, unlicensed or uncleared