Hahn: FDA May Keep Some COVID-19 Reforms Post-Pandemic

US FDA commissioner Stephen Hahn said during an 18 June “fireside chat” that he expects closer relationships with industry and a greater reliance on postmarket data to continue even after the COVID-19 pandemic comes to an end.

Stephen Hahn in his 1st address to the FDA January 30, 2020
Stephen Hahn

Changes made in response to the COVID-19 pandemic may be here to stay at the US Food and Drug Administration, commissioner Stephen Hahn said in a presentation organized as part of the Medical Device Innovation Consortium (MDIC)’s annual public forum on 18 June.

Hahn, who was sworn in as head of the agency last December, had only a few months as commissioner under...

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

NHS Orders Halt On Unapproved AI Scribes, Vendors Rush To Self-Certify

 

NHS England's national chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.

Time For Medtech To Have Its Say On Critical Changes In EU Framework Legislation

 

In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.

HHS Suggests Drastic Reductions To Skin Substitute Payments

 
• By 

The US Department of Health and Human Services has proposed cutting Medicare reimbursement for skin substitutes used in chronic wound care by up to 90%. The change aims to address rising costs but could harm patient access and treatment quality, prompting concerns from industry stakeholders.

International Reliance Gets UK MHRA OK In Drive For Agile Pre-Market Regulation – CE Marking Next

 
• By 

The UK government’s response to MHRA public consultation on risk proportionate device routes to market and physical UKCA markings adds momentum to drive for modern, agile system. Another consultation in late 2025 will propose indefinite recognition of CE-marked devices in Great Britain.

More from Policy & Regulation

NHS Orders Halt On Unapproved AI Scribes, Vendors Rush To Self-Certify

 

NHS England's national chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.

EU/US Trade Deal Raises Questions For Medtech

 

There is still no clarity on how life sciences will be treated in the final agreement.

NICE To Consult On UK Late-Stage Healthtech Assessments

 
• By 

NICE’s three-pronged lifecycle approach to healthtech evaluations includes late-stage assessments (LSA), which will be the focus of a short consultation in August.