hmholstein@hhlaw.com
V-CARD
PHONE
+1.202.637.5813
FAX
+1.202.637.5910
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Howard
M.
Holstein
Partner, Washington, D.C.
Howard Holstein's practice focuses on medical device law. He works extensively with large, small, and startup manufacturers on a broad spectrum of U.S. Food and Drug Administration (FDA) matters. He also assists companies in developing regulatory strategies and preparing product applications, including IDEs, 510(k)s, and PMAs; with compliance matters, including MDRs, recalls, and GMPs; in addressing regulatory due diligence issues; and with FDA training programs. Further, Howard counsels clients on product liability risk reduction techniques.
Prior to entering private practice in 1985, Howard had extensive FDA, industry, and government experience, having served as Deputy Chief Counsel at the FDA; as a general attorney at Merck and Company, where he was responsible for pharmaceutical research requirements; and as General Counsel of the Health Industry Manufacturers Association (HIMA) — the device industry's primary trade association. While at HIMA, Howard was responsible for all aspects of the industry's interactions with the FDA, including commenting on virtually all device regulations and product submission requirements.
Howard has written and spoken extensively on device and diagnostic issues, both in the United States and abroad.
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