Course Content

Howard Holstein

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Intellectual Property

Regulatory and Reimbursement

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Funding

Financials

Partner Hogan & Hartson LLp Washington, DC

Mr. Holstein's practice focuses on medical device law. He received his law degree from Georgetown University Law Center in 1972. Prior to entering private practice in 1985, Mr. Holstein had extensive FDA, industry, and government experience, having served as a Deputy Chief Counsel at FDA; a General Attorney at Merck and Company, 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, he was responsible for all aspects of the industry's interactions with the FDA, including commenting on virtually all device regulations and product submission requirements. Since entering private practice, Mr. Holstein has worked with large, small and start-up manufacturers on a broad spectrum of FDA matters. He focuses on assisting companies develop regulatory strategies and prepare product applications (IDEs, 510(k)s, and PMAs), compliance matters (MDRs, recalls, and GMPs), regulatory due diligence, and FDA training programs. He also counsels clients on product liability risk reduction techniques. Mr. Holstein has written and spoken extensively on device and diagnostic issues, both domestically and internationally. He has prepared regulatory manuals for CLINICA and Medical Device & Diagnostic Industry magazine. He also has served on the Editorial Board of the Food Drug Cosmetic Law Journal and the Board of Directors of the Regulatory Affairs Professionals Society.