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Gottlieb Defends US FDA 2019 Budget, Device Safety Plan In House

 
• By Sue Darcey

Members of a US House Appropriations Subcommittee interrogated FDA Commissioner Scott Gottlieb on the agency's proposed 2019 budget and his newly released device safety plan. One fierce critic, Rep. Rosa DeLauro, D-RI, attacked Gottlieb's efforts to allow third-party certifiers to approve device quality manufacturing processes, and said his safety plan looked like a "high-risk" action plan.

While US FDA Chief Scott Gottlieb's ongoing reforms and the agency's FY 2019 budget requests were well-received by most members of a House Appropriations Subcommittee hearing on April 17, some on the panel said Gottlieb's budget priorities would relax regulations too much.

Budget authority for the FDA device center would rise from $327m in 2018 to $455m in 2019, plus $180m in medical device user fees, under the proposal, and the entire FDA would see its total budget increase from $5.13bn in 2018 to $5.79bn next year. Part of the additional dollars would go to provide more regulatory incentives to manufacturers to "bring medtech manufacturing home," to reduce market-entry time for digital devices and improve cybersecurity oversight, among other goals

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

 
• By Brian Bossetta

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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.

Faster Device Certification Among Keys To Unlocking Innovation In EU MedTech Sector

 
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While MedTech Europe sharpens its focus on what the EU most urgently needs to advance the medtech market in four targeted measures, the European Commission has also unveiled four priorities for 2025.

More from Policy & Regulation

‘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.