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From hair removal lasers to spinal implants to heart valves, Mark Heller knows the law on medical devices. The chair of Wilmer Cutler Pickering Hale and Dorr’s Food and Drug Administration department, Heller, 58, is a veteran of both the FDA and the Federal Trade Commission. While in government, he played a key role in writing the landmark Safe Medical Devices Act of 1990. Today, he represents a broad range of medical device makers on all aspects of FDA product approval and compliance. He’s even written the book on it: Thompson Publishing’s Guide to Medical Device Regulation. Joseph Gulfo, president and CEO of Electro-Optical Sciences Inc., says he turns to Heller for his “intellectual horsepower” and his reputation as “someone the agency trusts.” Last year, Heller helped Electro-Optical swiftly secure a protocol agreement with the FDA for a clinical trial of MelaFind, a diagnostic system for the early detection of melanoma. “He gave us credibility and got us a very well-considered review by the agency,” says Gulfo, who also praises Heller for his “phenomenal job of working with my experts.” Getting the green light from the FDA is a Heller specialty. In 2004, he helped Philips Medical Systems obtain agency clearance for its prescription HeartStart Home Defibrillator, which is used to treat sudden cardiac arrest. He then worked with the company in early 2005 to get the FDA’s OK for the first over-the-counter defibrillator, intended for use in homes, businesses, schools, and other public institutions. Heller describes the work as “a particularly exciting public-health-focused project.” Heller has also represented KaVo Dental GmbH (now owned by the Danaher Corp.) in obtaining a risk-based class II classification for a noninvasive cavity-detecting device. Thus, the company could sell the product without first having to meet the FDA’s burdensome pre-market approval requirements. “He’s a brilliant guy,” declares Vivian Pratt, general counsel of Draeger Medical Inc., which makes anesthesia systems and other medical devices. “Anyone can give a focused, specific answer, but he looks at the broader implications for the product and the business.” Over the past 10 years, Pratt says, she has turned to Heller for assistance on device and drug matters ranging from interpretation of detailed requirements of the Federal Food, Drug, and Cosmetic Act to strategic advice on FDA compliance and product approval. Heller’s practice has a significant public policy component as well. In recent years, he has registered as a lobbyist for such companies as Hillenbrand Industries, Cook Group Inc., and FujiFilm Medical Systems USA Inc. Representing the Advanced Medical Technology Association (AdvaMed), Heller helped draft several provisions of the Food and Drug Administration Modernization Act of 1997. The law, says Heller, “streamlined pre-market clearance and put into place risk-based classifications.” He also represented AdvaMed in connection with the Medical Device User Fee and Modernization Act of 2002. Heller is a 1973 graduate of the University of Wisconsin Law School. He joined the FTC in the Bureau of Consumer Protection’s national advertising division, where virtually all his work concerned the food and drug industry. In 1981, Heller moved to the FDA as associate chief counsel for enforcement, and in 1984, he was named associate chief counsel for medical devices. Highlights of his FDA tenure include successfully litigating in Michigan federal court in 1986 against the Stryker Corp. over a shoulder prosthesis marketed without appropriate clearance. In 1991, he won a case involving synthetic, absorbable sutures against Johnson & Johnson subsidiary Ethicon Inc. in D.C. federal court. That case, says Heller, “helped clarify FDA reclassification standards.” While officially at the FDA, Heller was also detailed to the Senate Committee on Labor and Human Resources to advise the chairman at the time, Sen. Edward Kennedy (D-Mass.). Heller’s job: helping to draft the Safe Medical Devices Act. “It was an absolutely wonderful experience,” remembers Heller. “One real thrill in doing legislative work is that it allows you to participate in and witness the evolution of a body of law.” In 1991, Heller joined Patton, Boggs & Blow as a partner. Six years later, he moved to the D.C. office of Hale and Dorr, now part of Wilmer Cutler Pickering Hale and Dorr.

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