The US Food and Drug Administration (FDA) proposed revisions to its medical device regulations to end the practice of publishing quarterly lists of its approval or denial decisions for premarket approval applications (PMAs) and humanitarian device exemptions (HDEs). FDA says the rule will improve efficiency and eliminate duplication in publishing PMA and HDE decisions, as the agency publishes the same information, along with summaries of safety and effectiveness data (SSED) for PMAs and summaries of safety and probable benefit (SSPB) for HDEs, on its website.
Proposed Rule
According to the FDA, it is proposing 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.”
It states it is also proposing to update the agency’s contact information and other statutory references in sections of the PMA and HDE regulations for accuracy, clarity, and consistency.
According to the agency’s statements related to the major provisions of the rule, the “FDA is proposing to amend its regulations regarding the announcement procedures for the approval and denial of PMAs and HDEs. FDA is proposing to discontinue publishing in the Federal Register after each quarter a list of PMA and HDE approvals and denials announced for that quarter. We will continue to post approval and denial notices for PMAs and HDEs on FDA’s home page on the internet, and we will also continue to make SSED for PMAs and SSPB for HDEs available on the internet and place them on public display.”
“The proposed rule, if finalized, would allow FDA staff to focus on other agency priorities and utilize FDA staff resources more efficiently,” FDA writes, noting that the rule would save the agency about $10,000 over 10 years.