Bioelectronics Corp (BIEL)

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The Law Firm of Goodwin Procter disagrees with your theory.

Poster wrote "Because there is no predicate device that the FDA will accept for 510(k) OTC clearance of the ActiPatch"

Goodwin Procter advised BIEL and crafted the 510K submission. GP has lawyers with decades of experience working inside the FDA. Their Senior FDA Attorney is Mark Heller who has 16 years experience working for the FDA including 6 years as the Associate Chief Counsel for Medical Devices.

So, and this is a tough one, who should board members put there faith in, an anonymous poster who says "No Predicate", or Mark Heller who crafted the 510K?

"Prior to joining Goodwin in 2007, Mr. Heller was chair of the FDA Department at WilmerHale. Before that, he spent almost 10 years in the FDA’s Chief Counsel’s office, where he was actively involved in offensive and defensive litigation, including drug and device cases. During his last six years with the FDA, Mr. Heller was the Associate Chief Counsel for Medical Devices, responsible for the legal aspects of the agency's combination product, device enforcement, premarket notification, investigational device exemption, reclassification and premarket approval programs. He also was involved in the development of the Safe Medical Devices Act of 1990 while on detail to the office of the chairman (Senator Edward M. Kennedy) of the Senate Committee on Labor and Human Resources."

"Before joining the FDA, Mr. Heller was with the Federal Trade Commission for eight and a half years. He focused on the regulation of food, drug and device advertising. Mr. Heller has received several awards for excellence for his work at both the FDA and FTC."


"Goodwin Procter LLP is the 35th [1]wealthiest American law firm, consisting of more than 900 lawyers with offices in Boston, Frankfurt, Hong Kong, London, Los Angeles, New York City, Paris, Silicon Valley, San Francisco and Washington, D.C. Goodwin focuses on complex transactional work and high-stakes litigation in matters involving financial institutions, intellectual property, private equity, real estate capital markets, securities litigation/white collar defense, and technology/life sciences."