The Food and Drug Administration 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). This proposed rule, if finalized, would result in cost savings to FDA from discontinuing publishing in the Federal Register, on a quarterly basis, a list of medical device PMA and HDE approvals and denials. Discontinuing publishing Federal Register notices with these approval and denial lists would eliminate duplication in announcing this information; information on these approvals and denials would continue being readily available to the public on FDA’s home page on the internet (https://www.fda.gov). Annualized over 10 years, the estimated benefits (i.e., cost savings) to FDA would range from $0.008 million to $0.013 million at both 3 and 7 percent discount rate, with a primary estimate of $0.010 million. This proposed rule, if finalized, would result in no costs to industry because the rule would not require performance of any additional tasks and, therefore, would not impose any additional regulatory burden on the industry.

Regulatory Impact Analysis

Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications (Proposed Rule) Regulatory Impact Analysis (PDF- 100KB)

Federal Register: 84 FR 68829 (December 17, 2019)

Docket: FDA-2019-N-3101