Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications (Final Rule) Regulatory Impact Analysis
The Food and Drug Administration is issuing a final rule 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 final rule discontinues the publication in the Federal Register after each quarter of a list of PMA and HDE approvals and denials announced in that quarter. FDA is taking 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. Information on these approvals and denials will continue to be 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) 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 rule will result in no costs to industry because the rule does not require performance of any additional tasks and, therefore, does not impose any additional regulatory burden on the industry.
Regulatory Impact Analysis
Federal Register: 87 FR 2042 January 13, 2022
Docket: FDA-2019-N-3101