WASHINGTON, DC, August 29, 2017: Morgan Lewis partner Michele Buenafe has been recognized by The National Law Journal in its 2017 list of “Rising Stars” in Washington, DC. Ms. Buenafe is one of only 40 lawyers chosen to be featured in the annual report, which identifies top legal talent under the age of 40 based on his or her "success on the highest stages" and by the recommendations received in support of a candidate's nomination.
Ms. Buenafe was chosen based on her extensive work in the area of medical device and digital health regulation, including her 2016 efforts to help client ImPACT Applications Inc. identify a US Food and Drug Administration (FDA) regulatory pathway for its software-based cognitive test systems. As a result of her work, ImPACT’s test systems received marketing clearance from the FDA as the first FDA-cleared devices to be used to assess cognitive function following a possible concussion.
A partner in Morgan Lewis’s nationally recognized FDA practice and co-leader for the firm’s cross-practice healthcare initiative, Ms. Buenafe advises clients on regulatory, compliance, and enforcement issues related to the development, manufacturing, marketing, labeling, and advertising of medical devices, human tissue products, pharmaceuticals, controlled substances, listed chemicals, and combination products. She also advises clients on emerging legal issues relating to digital health platforms such as mobile medical apps, clinical decision support software, telemedicine systems, wearable devices, and other health information technology.