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

US FDA's 'Program Alignment' Inspection Scheme Coming Mid-May; Details Still Murky

 
• By Shawn M. Schmitt

The agency's new inspectional approach – which will be structured along commodity-specific product lines – will be ready for primetime on May 15, the device center's compliance chief says.

Mark your calendar: US FDA investigators will begin inspecting device manufacturing facilities using the agency's brand-new "program alignment" inspectional approach on May 15.

That's according to Robin Newman, director of the Office of Compliance within FDA's Center for Devices and Radiological Health, who...

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 Compliance

Former Top OIG Attorney Gives Inside Look At Fraud Prevention

 
• By Elizabeth Orr

Former HHS-OIG attorney Rob DeConti emphasized the significance of data analytics and compliance in combating healthcare fraud, urging medical tech companies to adopt robust measures to prevent potential risks.

‘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.

New Draft Guidance Clarifies FDA’s UDI Rules For Combination Products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The FDA has released draft guidance clarifying UDI rules for drug- and device-led combination products.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.

DME And Diagnostics In Crosshairs As DOJ ‘Follows The Money’

 
• By Elizabeth Orr

The DOJ has launched nearly 70 enforcement actions in 2025, targeting diagnostics, durable medical equipment, and telehealth fraud. Key cases involve significant fraudulent claims against Medicare, with individuals facing severe penalties.

More from Policy & Regulation

Deaths And Serious Injuries Linked To A Pair Of Heart Device Recalls

 
• By Brian Bossetta

Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.

‘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.