Notice of Followup to Notice of Public Hearing and Request for Comments on Devices Proposed for a New Use With an Approved, Marketed Drug

Streszczenie

The Food and Drug Administration (FDA, the Agency, or we) is announcing a followup on a Federal Register document issued on September 26, 2017, that announced a public hearing and requested comments on a potential approach to enable device sponsors to obtain marketing authorization for their products labeled for a new use with an approved, marketed drug when the sponsor for the approved drug does not wish to pursue or collaborate on the new use, referred to in the notice as devices referencing drugs (DRDs). After further consideration and in light of the comments received, FDA does not intend to pursue the potential approach described in the referenced Federal Register document at this time.