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

Bye-Bye QSR? FDA May Swap Its Quality System Regulation For ISO 13485 'In The Coming Years,' Official Says

 
• By Shawn M. Schmitt

The US agency's 22-year-old bedrock rule for making safe and effective medical devices to be sold in the United States will likely be replaced with international quality systems standard ISO 13485, FDA official Sean Boyd said at MedCon 2018. But the author of the Quality System Regulation, Kim Trautman, told Medtech Insight that it would be a thorny, years-long chore for the agency.

MT1805_Power Saving_790594240_1200.jpg

FDA's Quality System Regulation – the bedrock rule for manufacturing safe and effective medical devices to be sold in the United States for more than two decades – will likely be replaced with international quality systems standard ISO 13485, an agency official says.

Sean Boyd, deputy director for regulatory affairs for the Office of Compliance within FDA's Center for Devices and Radiological Health, said the agency is considering how it "can better converge...

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

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 
• By Brian Bossetta

The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.

State And International Enforcement Agencies May Step Up Amid Uncertain Federal Environment

 
• By Elizabeth Orr

States and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.

Don’t Sleep On Inspections: Experts Warn FDA Maintains Enforcement Resources

 
• By Brian Bossetta

Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.

More from Policy & Regulation

First Alzheimer’s Disease Diagnostic Blood Test Cleared By FDA

 
• By Natasha Barrow

Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.

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.

Debate On FDA User Fee Reauthorization Begins To Take Shape

 
• By Elizabeth Orr

A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.