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A proposal from the US FDA would end quarterly publication of PMA and Humanitarian Device Exemption verdicts in the Federal Register. The agency says the practice is inefficient and duplicates online publication.

 

FDA_Proposes_End_To_Quarterly_Reporting


The US Food and Drug Administration would stop publishing recent PMA and Humanitarian Device Exemption (HDE) approvals or denials in the Federal Register at the end of each quarter under a proposed rule issued on 17 December.

The agency says the move will increase efficiency and reduce duplicative announcements.

Approval and denial notices would still be posted to the FDA’s website under the proposal, and the agency would continue to post summaries of safety and effectiveness data (SSED) for PMAs and summaries of safety and probable benefit (SSPB) for HDEs, as well as putting the information on display under the proposal, which was published in the 17 December Federal Register.

“The proposed rule, if finalized, would allow FDA staff to focus on other agency priorities and utilize FDA staff resources more efficiently,” the proposal explains.

The agency estimates that the change could save $8,000 to $13,000 per year, without passing any costs along to industry.

As well as eliminating quarterly publication of PMA and HDE decisions, the proposed rule includes some needed updates to regulatory language . It will direct requests for copies of current PMA approvals and denials documents and copies of SSED to Freedom of Information staff, rather than to the Division of Dockets Management, per current FDA practice. Additionally, it replaces some outdated references to sections of the Food, Drug and Cosmetic Act.

Comments on the proposal are open at Regulations.gov under Docket No. FDA-2019-N-3101-0001 through 2 March 2020.

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