FDA Wants to End Quarterly Reporting of Device Decisions

Regulatory NewsRegulatory News | 16 December 2019 |  By 

The US Food and Drug Administration (FDA) on Monday proposed revisions to its medical device regulations to end its practice of publishing quarterly lists of its approval or denial decisions for premarket approval applications (PMAs) and humanitarian device exemptions (HDEs) in the Federal Register.
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.
While the Federal Food, Drug, and Cosmetic Act does not require FDA to publish the approval or denial of PMAs and HDEs in the Federal Register, FDA has issued rules requiring the publication of those decisions in the 1980s and 1990s. In 1998, FDA issued a final rule that ended individual Federal Register notices for PMA approvals and denials and instituted the quarterly lists the agency currently publishes.
“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.
FDA says that the public will still have an opportunity to request the review of PMA and HDE decisions and that the 30-day period for requesting reconsiderations will begin when notice of a decision is placed on its website.
The proposed rule would also revise regulations for requesting copies of current PMA approvals, denials and SSEDs to direct requests to the agency’s Freedom of Information staff rather than the Division of Dockets Management.


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy