1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Regulation

FDA 2024: Watch For Trial-Diversity Guidance, Final Quality Systems Rewrite

 
• By Elizabeth Orr

Industry observers at RAPS Convergence in Montreal last week said the FDA’s agenda for 2024 is likely to include increased emphasis on MDUFA goals, enhanced cybersecurity requirements, the new QMSR, and more. 

People in business attire peep through binoculars behind the word 2024.
• Source: Shutterstock

Watch for the US Food and Drug Administration to act on a trial diversity guidance, enhanced device cybersecurity, the revised quality systems regulations, and more in 2024, two industry observers said at the Regulatory Affairs Professionals Society (RAPS) Convergence meeting in Montreal.

The 4 October session was led by Alexander Gaffney, executive director of regulatory policy and intelligence at Politico’s AgencyIQ, and

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Regulation

Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 
• By Amanda Maxwell

Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.

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.

More from Conferences

AAOS 2025 Orthopedic Roundup: J&J Velys UKA, Stryker Mako 4, Materialise, Canary Medical

 
• By Marion Webb

At AAOS, orthopedics players showcased their latest robotic-assisted platforms, power tools, 3D printed technologies and software offerings. This article brings you highlights from interviews Medtech Insight conducted on site with representatives from J&J, Stryker, Materialise and Canary Medical.

LSX Roundup: Startups Elypta, QuantiLight And Plexaa Debut New Tech

 
• By Natasha Barrow

Back-to-back meetings at LSX? No time to attend the innovator showcase? Here is what you might have missed from medtech innovators at the LSX World Congress Europe on 29 April.

Medtronic Presents Data To Boost Hugo’s Odds Of Getting FDA Nod

 
• By Brian Bossetta

Medtronic says results from a recent study on the Hugo robotic-assisted surgery system substantiate its safety and effectiveness for various urological procedures. The company also announced it has submitted the system to the FDA for approval for a urological indication.