2019-27045: Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications

Summary

The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the medical device regulations regarding the procedures for the announcement of approvals and denials of premarket approval applications (PMAs) and humanitarian device exemption applications (HDEs). We are proposing to discontinue publishing in the Federal Register after each quarter a list of PMA and HDE approvals and denials announced in that quarter. We will continue to post approval and denial notices for PMAs and HDEs on FDA's home page on the internet and will also continue to make available on the internet and place on public display summaries of safety and effectiveness data (SSED) for PMAs and summaries of safety and probable benefit (SSPB) for HDEs. FDA is proposing to take this action to improve the efficiency of announcing approvals and denials of PMAs and HDEs and to eliminate duplication in the current process for announcing this information. We are also proposing to update Agency contact information and statutory references in certain sections of the PMA and HDE regulations for purposes of accuracy, clarity, and consistency.

The agency’s own summary, as published.

What this changes

Amends 1 part of the Code of Federal Regulations — the standing rules this notice rewrites.

• 21 CFR 814 Premarket Approval of Medical Devices