Pharma Intelligence is part of the Informa Intelligence Division of Informa PLC
This is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.
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.
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 Additionally, it replaces some outdated references to sections of the Food, Drug and Cosmetic Act.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.
Medtech Insight: global medical technology news & analysis
By Elizabeth Orr 26 Jul 2021
Increased demand tied to COVID-19, plus supply chain difficulties, led to the blood collection device shortage, the US agency says.
Medtech Insight: global medical technology news & analysis
By Ferdous Al-Faruque 26 Jul 2021
Experts representing manufacturers, patients, providers and federal agencies are being sought by the US government to advise the Office of...
Medtech Insight: global medical technology news & analysis
26 Jul 2021
Medtech Insight’s second bimonthly digest of Chinese medtech industry news sourced from Omdia includes updates on the national device regulator’s...
Request a Trial
Whether you’re a small biotech start-up, research firm, generic manufacturer or a global pharmaceutical giant, you need focused, independent insight and opinion on market developments.
How can we help you?
Our team is always happy to hear from you. Please call us at:
Pharma Report Store
Have an immediate and specific information need?
Browse and buy from 1000s of analysis and research reports now:
In the continually evolving medtech competitive landscape, it is vital to stay up-to-date with key events. With Meddevicetracker, you’ll be able to anticipate upcoming filings, research clinical trial dates and data, and access market size information and expert forecasts, all in one place.
Get a window into what the leading players across the biopharma, medtech, and diagnostics industries are thinking, as well as important insight into what your competitors are doing. Build your strategy with In Vivo.
Looking for more products Product Finder
