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FDA Plans To Continue Diagnostics Reform Fight

 
• By Elizabeth Orr

In a recent webinar about the agency’s current regulatory and legislative priorities, FDA Deputy Commissioner Andi Fristedt called the way diagnostics are now regulated “untenable.”

Boxing Gloves Ring Red
• Source: RossHelen editorial / Alamy Stock Photo

The US Food and Drug Administration will keep working to improve diagnostics regulation despite recent legislative setbacks, Andi Lipstein Fristedt, deputy commissioner for policy, legislation, and international affairs, said during a recent webinar sponsored by the Alliance for a Stronger FDA.

Fristedt’s office serves as the FDA’s main point of contact with Congress, regularly answering lawmakers’ requests for agency briefings or...

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More from Regulation

EU Life Sciences Strategy Must Address ‘Regulatory Lasagna’

 
• By Amanda Maxwell

MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”

FDA Publishes Final Cybersecurity Guidance To Replace Final Cybersecurity Guidance

 
• By Brian Bossetta

The US FDA has issued an updated final guidance document on cybersecurity considerations for medical device manufacturers that replaces a previous final guidance the agency issued in 2023.

New Regulation Significantly Expands eIFU Usage Scope

 
• By Amanda Maxwell

Amendment brings new benefits for device accessories and aesthetic devices used by healthcare professionals.

New EU Rules Limit Chinese Participation In Medtech Procurement

 
• By Amanda Maxwell

From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.

More from Policy & Regulation

‘Be Quick, But Don’t Hurry’: Dexcom CEO Talks CGM Market Success

 
• By Marion Webb

Dexcom’s CEO Kevin Sayer discusses this fall’s planned launch of the 15-day G7 CGM, downplays Abbott’s dual-sensor while focusing on development of multi-analyte G8, making OTC Stelo app more “consumerish” for Europeans, and more.

June 2025: A Bumper Month For New EU Medtech Documents And Initiatives

 
• By Amanda Maxwell

The rate at which new documents to support the implementation of EU medtech regulations are issued has slowed of late; but June bucked the trend, with a flurry of activity.

New Draft Guidance Clarifies FDA’s UDI Rules For Combination Products

 
• By Elizabeth Orr

The FDA has released draft guidance clarifying UDI rules for drug- and device-led combination products. The document specifies labeling requirements and makes recommendations to reduce confusion between UDIs and NDCs. Comments are being accepted until Sept. 24.