FDA Law Blog: Device Developments – The Medical Device Amendments May be Over-the Hill but Device Regulation is Still Very Active

FDA Law Blog: Device Developments – The Medical Device Amendments May be Over-the Hill but Device Regulation is Still Very Active

Device Developments – The Medical Device Amendments May be Over-the Hill but Device Regulation is Still Very Active

Posted: 08 Aug 2016 06:26 AM PDT

This spring marked the 40th Anniversary of the Medical Device Amendments.  Thanks to significant technological advancements there is no sign of slowing down for medical device regulatory developments.  Devices were a prominent focus at this year’s Food and Drug Law Institute’s Annual Conference.  Sessions included digital health, including wearables and clinical decision support software, laboratory developed tests, and combination products.  Dr. Shuren also discussed the Center’s top priorities, highlighting the National Medical Device Evaluation, which we have blogged on previously (here, here, and here). In a new article in FDLI’s Update Magazine, titled “Devices May Be Over-the-Hill, but Regulatory Developments and Challenges Show No Signs of Slowing Down,” Hyman, Phelps & McNamara, P.C.’s Allyson Mullen discusses medical device developments and highlights from FDLI’s Annual Conference.