1. Medtech Insight
  2. >>Digital Technologies
  3. >>AI

FDA Publishes 5 PCCP Principles For ML Devices In Collaboration With Canada And UK

 
• By Hannah Daniel

Five guiding principles for PCCPs for ML devices exemplify international harmonization efforts from regulators.

Buttons in a pile with the Canadian, US, and UK flags.
• Source: Shutterstock

Five principles recently published by the US Food and Drug Administration in collaboration with Health Canada and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), are laying the foundation for international harmonization of regulations for pre-determined change control plans (PCCP) for machine learning-enabled devices.

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 AI

Biolinq’s $100M In Series C Financing Supports Efforts To Bring Diabetic Glucose Monitoring With Needle-Free Patch To Market

 
• By Marion Webb

Biolinq plans to use the proceeds of its new venture funding to support US FDA de novo review, automation engineering and commercialization efforts with partners, CEO Rich Yang told Medtech Insight.

OneCell Diagnostics – Now 1Cell.Ai - Launches Multi-Modal Cancer Diagnostic Panel OncoIncytes

 
• By Natasha Barrow

OneCell Diagnostics, the Mumbai-based startup backed with $16m in series A funding, is rebranding to 1Cell.Ai to represent the firm's focus on combining deep science with AI-powered capabilities.

J&J Survey: Clinician Burnout And Aging Populations Drive Demand For AI And Robotics In Future Health Care

 
• By Shubham Singh

According to a survey of health care professionals by J&J, over 45% of surveyed respondents reported experiencing symptoms of burnout, including emotional exhaustion and reduced sense of personal accomplishment. This affects not just clinicians, but also the quality and safety of care they deliver. Most clinicians (72%) say that data and technology could significantly help alleviate this burden.

Looking Back Towards The Future

 
• By Brian Bossetta

As it celebrates 75 years shaping the medtech industry, Medtronic invited Medtech Insight to its Minneapolis headquarters to get a closer look at the company’s past, what it’s working on now, and what’s on the horizon.

More from Digital Technologies

Guidance Feedback Highlights Outstanding Questions In AI Development

 
• By Elizabeth Orr

Many of the hundred-plus commenters to the FDA's draft guidance on AI in medical product regulation said the document was a good start but needed additional clarity and more concrete examples. Stakeholders recommended the inclusion of case studies, metrics, and clearer guidelines to enhance the utility of the guidance, which is seen as a vital step for AI integration in healthcare.

MedStar Teams Up With Reimagine Care To Extend Cancer Care Into Patients’ Home

 
• By Marion Webb

Reimagine Care teamed up with MedStar Health to support cancer patients at home via an AI assistant and clinical support. Reimagine Care’s data suggests its platform can save cancer centers up to $1m annually per full-time oncologist panel and reduce ED visits by 30%.

Anglonordic 25: Pictura Bio’s One-Minute Pathogen-Identifying Diagnostic Test

 
• By Natasha Barrow

“Infectious disease should be treated in the community, not in hospitals,” Alex Batchelor, Pictura Bio CEO, told Medtech Insight at the Anglonordic Life Science Conference on 3 April in London.