Gottlieb At The Medtech Conference: US FDA Commissioner Talks About CDRH Innovation, Puerto Rico, LDTs And More

Check out the full video and read the highlights of US FDA Commissioner Scott Gottlieb's keynote address and Q&A from AdvaMed's 2017 Medtech Conference. Among the issues addressed: Gottlieb touted the agency's device center as the spark of innovation within FDA, and he provided a key update to the agency's digital-health regulation, his hopes for lab-developed test regulations and some substantive points on how industry should respond to the ongoing devastation in Puerto Rico from Hurricane Maria.

FDA commissioner Scott Gottlieb
Scott Gottlieb

FDA Commissioner Scott Gottlieb gave the keynote address Sept. 26 at AdvaMed's Medtech Conference, and he also sat down with AdvaMed President and CEO Scott Whitaker for a public question-and-answer session.

During the conference, in San Jose, Calif., the commissioner touted the agency's device center as the spark of innovation across FDA. He also provided a key update in the agency's...

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

More from Regulation

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

 

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 

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

 

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

 

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 Policy & Regulation