Westlaw Publishes Brown, Sklamberg, Carey Article on Legal, Regulatory Issues for Medtech in 2020

Thomson Reuters Westlaw has published “MedTech update 2020 — Legal and regulatory issues to watch for in the medical technology industry in the new year: FDA regulatory developments.” The article, which originated as part of a longer Akin Gump client alert, was written by health care and life sciences partners Nathan Brown and Howard Sklamberg and counsel Christin Carey.

The article reports on topics related to U.S. Food and Drug Administration regulatory actions in 2020, with the authors noting that, worldwide, countries such as India and China and the EU member states are “revamping their regulatory oversight of medical technologies.” They state that FDA is “not standing pat, either” and will “continue advancing new approaches to premarket review, particularly for novel device technologies.”

Among the approaches they discuss are FDA’s Software Pre-Certification Pilot Program, medical software employing artificial intelligence and machine learning, an alternative 510(k) pathway and the agency’s Safer Technologies Program.

The authors also look at FDA’s evolving postmarket expectations, noting the agency’s postmarket oversight of devices “has undergone dramatic restructuring, through the development of product-specific inspection cadres under the agency’s Program Alignment and through the reorganization of the Center for Devices and Radiological Health, to embrace a ‘total product  life cycle’ approach to device oversight.”

To read the article in its entirety, please click here.