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Expert: FDA’s Highly Anticipated PCCP Guidance Isn’t Anything Too ‘Surprising’

 
• By Hannah Daniel

The FDA’s highly anticipated predetermined chance control plan (PCCP) guidance document is pretty much what the industry expected, Sidley Austin partner Deeona Gaskin told Medtech Insight.

• Source: Shutterstock

Since 2019, manufacturers of medical devices with artificial intelligence and machine learning capabilities have been awaiting official guidance on submitting post-market changes to the US Food and Drug Administration.

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Many of the hundred-plus commenters to the FDA's draft guidance on AI in medical product regulation said the document was a good start but needed additional clarity and more concrete examples.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.

IMDRF Offers Granular Playbook On ‘Regulatory Reliance’ Program Development And Implementation

 
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International device regulatory group IMDRF has issued a new playbook on “regulatory reliance,” which allows regulators to make use of assessments performed by trusted regulatory partners. The document is the first to offer a detailed guide on developing and implementing these agreements.

Global Medtech Guidance Tracker: March 2025

 
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HIMSS 2025: Interview with Aneesh Chopra, Arcadia’s Chief Strategy Officer, About The Future Of Health Data, Interoperability, AI

 
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Medtech Insight sat down with Arcadia's chief strategy officer Aneesh Chopra to discuss interoperability, industry standards and the future of health care data and AI.

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Global Medtech Guidance Tracker: March 2025

 
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AI-Based Screening Tool For Musculoskeletal Issues Gets US FDA Warning Letter

 
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Exer Labs Inc.’s website marketed its AI-based Exer Scan app to “screen and treat Parkinson’s, TB, Cerebral Palsy and more.” But those claims went well beyond what was allowed under the product’s 510(k) clearance, US regulators say.

New CLIA Rule Updates Personnel Policies

 
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