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Risks Of Missing Reauthorization Deadline Highlighted At User-Fee Hearing

 
• By Sue Darcey

FDA center directors, including device chief Jeffrey Shuren, told lawmakers they are committed to reauthorizing user-fee programs during a March 21 Senate hearing. The officials wouldn't comment on a recent budget proposal from the Trump administration that seeks more user fees and less appropriations from Congress that industry agreed to.

FDA product-center directors wouldn't comment on whether any alternative user-fee provisions were under consideration during a March 21 Senate hearing, despite a recent budget blueprint from the Trump administration that appears to seek more user fees from companies next year than what industry agreed to in recent negotiations.

FDA Device Center Director Jeffrey Shuren testified before the Senate Health, Education, Labor and Pensions (HELP) Committee on the medical...

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More from Regulation

UK MHRA Ready To Evolve Approach To In-House Manufactured Medtech

 
• By Ashley Yeo

The UK device regulator wants to align health institution device exemptions with its evolving policy of agile regulation of medtech in the British market. It asks stakeholders to complete a survey by Sept. 15.

FDA Panel Supports Dermal Fillers For Décolletage Use

 
• By Elizabeth Orr

An FDA panel has endorsed the use of dermal fillers for décolletage, but warned of patient safety concerns. The filler can cause complications with future imaging and pregnancy or breastfeeding, panelists said. Regulatory measures and patient studies are recommended for better outcomes.

FDA Changes Fail To Diminish US Appeal To European Medtech Industry

 
• By Amanda Maxwell

Despite staffing cuts and uncertainty at the FDA, the US still offers EU medtech firms stronger regulatory support, regulatory expert Bassil Akra told Medtech Insight. This is especially valued as EU rules are often viewed as overly stringent, unclear and difficult to follow.

Environmental Group Questions FDA’s Stance On PFAS In Medical Devices

 
• By Brian Bossetta

The US FDA says PFAS used in medical devices are safe and that there’s no reason to restrict them in device production. An environmental group finds the agency’s assertion questionable.

More from Policy & Regulation

FDA Panel Supports Dermal Fillers For Décolletage Use

 
• By Elizabeth Orr

An FDA panel has endorsed the use of dermal fillers for décolletage, but warned of patient safety concerns. The filler can cause complications with future imaging and pregnancy or breastfeeding, panelists said. Regulatory measures and patient studies are recommended for better outcomes.

NAD Alerts Agendia Over Endorsing Physician’s Ties To Firm

 
• By Elizabeth Orr

The National Advertising Division (NAD) alerted Agendia to improve disclosure regarding a physician endorsing its MammaPrint test. The physician's ties to Agendia were inadequately revealed in LinkedIn posts.

FDA Ends Effort To Regulate LDTs By Rescinding Final Rule

 
• By Brian Bossetta

Just a year and four months after publishing a final rule that would have allowed it to regulate laboratory developed tests as medical devices, the US FDA has rescinded the controversial measure, finally putting an end to the saga.