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FDA 'Cures' Fund Breakdown: Breakthrough Devices, HDEs, IRB Flexibility And More

 
• By Sue Darcey

FDA's device center 'has a lot of work ahead of us,' to implement not only the 21st Century Cures Act, but also maintain performance goals for device and drug reviews, speakers said at a Food Drug Law Institute meeting May 5. The agency released a proposed work plan for use of 'Cures' Innovation Account funds, with dollars detailed for the device side on breakthrough devices, humanitarian device exemptions, and least burdensome device provisions, among others, as spelled out for use at a May 8-9 Science Board meeting.

US FDA's device center has "a lot of work ahead of us" to respond to the new provisions enacted Dec. 13 in the 21st Century Cures Act, says Jonette Foy, acting associate director for policy of FDA's Center for Devices and Radiological Health.

The center, along with the rest of the agency, will rely on additional funds provided by Congress to support implementation of the Cures Act. Foy spoke on a panel May 5 at the Food, Drug Law Institute annual meeting in Washington, DC, about FDA's plans for the Cures reforms. The discussion occurred on the same day that the agency released its proposed FDA

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More from Regulation

MORE Details On MHRA’s Online Platform For Post Market Surveillance

 
• By Ashley Yeo

Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.

‘Help Us Deregulate’: RFK Announces RFI For Trimming Government Health Agencies

 
• By Brian Bossetta

HHS Secretary Robert F. Kennedy, Jr. is asking the public to help cut waste across the government’s health agencies. Kennedy announced a 60-day comment period allowing the public to take part in a broader federal initiative to reduce regulations and increase transparency.

MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 
• By Amanda Maxwell

The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.

UK Medtech Regulators Must Ensure Certainty So Businesses Can Plan Their Futures

 
• By Ashley Yeo

With medtech businesses typically managing investment cycles on a three- to five-year basis, local regulatory processes and forward costs of market entry must offer an attractive environment in which companies can plan for growth, says McDermott Will and Emery’s partner and head of healthcare and life sciences, Sharon Lamb. Broad-scale improvements to NICE’s evaluation offerings would similarly enhance the UK’s value to innovators.

More from Policy & Regulation

Tariffs Threaten Medtech Innovation And US Position As World Leader, Whitaker Tells Lawmakers

 
• By Brian Bossetta

During his testimony before US senators on the impact of tariffs on critical supply chains, AdvaMed’s Scott Whitaker said the Trump tariffs could jeopardize America’s preeminence in medtech. Other industry experts echoed similar concerns.

Califf Warns Progress May Be In Danger Due To ‘Decimated’ FDA Staff

 
• By Barnaby Pickering

In Vivo spoke to the previous commissioner of the US FDA about recent ongoings at the agency, and where he believes policy should be directed for patient and industry benefit.

What’s A Diagnostic? WHO Wants To Know

 
• By Elizabeth Orr

The World Health Organization is seeking input from stakeholders to create an official definition of the term ‘diagnostics.’ This initiative follows a 2023 resolution aimed at enhancing global diagnostics capacity; the definition, it is hoped, will help drive the creation of effective health policies. Comments will be accepted until 23 May.