Brett Mason

Dec 7, 2024 | meddeviceonline.com | Mark Witcher |Allan Marinelli |Abhijit Menon |Brett Mason

This article puts a new lens on the risk model in Annex C of ISO 14971 using relational risk analysis to describe a better approach for understanding and managing medical device risks. In part 2 of the authors' series on computer systems validation pitfalls, they cover misinterpretations and unnecessary "nice to haves" that waste execution efficiencies.

Nov 19, 2024 | meddeviceonline.com | Brett Mason |Troutman Pepper |Rob Haley

Get the latest industry news and expert insights delivered straight to your inbox! Newsletter | November 19, 2024 As the FDA continues to develop and solidify its guidance and regulations on AI, medical device manufacturers should prepare to navigate new legal challenges, as well as evolving safety and compliance risks.

Nov 1, 2024 | meddeviceonline.com | Brett Mason |Troutman Pepper

By Brett Mason, Troutman Pepper With the rise AI-enabled medical devices, the FDA is soliciting comments and feedback regarding the importance of AI safety and effectiveness considerations in advance of its upcoming Digital Health Advisory Committee Meeting.

Jul 9, 2024 | today.westlaw.com | Brett Mason |Emma Trivax |Troutman Pepper

(July 09, 2024) - Troutman Pepper attorneys Brett Mason and Emma Trivax discuss recent efforts in Georgia and other states to enact legislation that places "guardrails" on the use of artificial intelligence in health care settings. AI is poised to revolutionize the health care industry with its capacity to make complex health decisions — whether it's making an insurance coverage determination or identifying the most optimal medical treatment for a patient. But is the AI risk worth the reward?

Apr 12, 2024 | jdsupra.com | Kyle Dolinsky |Linnea J. Kelly |Brett Mason

On March 15, the U.S. Food and Drug Administration (FDA) published a paper titled " Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together." This paper describes the FDA's strategy for incorporating artificial intelligence (AI) into medical products within the FDA's Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Office of Combination Products...