news February 6, 2019

Prominent Medical Device Attorney, Neil O’Flaherty, Joins Amin Talati in Washington, DC

Neil O’Flaherty has over 28 years of experience involving FDA regulation of medical devices and other products. He has spoken, written and advised extensively on medical device and other FDA-related topics, including the regulation of mobile medical apps and other medical software products, in vitro diagnostics (including genetic and other laboratory tests), human cells, tissues, and cellular and tissue-based products (HCT/Ps), FDA’s inspectional and enforcement authority, clinical trial requirements for devices, device regulatory obligations of hospitals, and the impact of FDA regulation on business transactions and agreements. He regularly obtains device marketing approvals and clearances, conducts FDA compliance audits and internal investigations for clients, and leads FDA regulatory due diligence assessments as part of mergers, acquisitions and other business transactions.

Mr. O’Flaherty joins the firm from Baker McKenzie, where he was a partner in the Intellectual Property Practice Group in Washington, DC and a member of the North America Healthcare Group.

“I was drawn to Amin Talati’s energy and focus on FDA regulatory and intellectual property matters,” said Mr. O’Flaherty. “It is also a unique and exciting opportunity to join a growing firm that has earned a national reputation for excellence in the industries it serves. I am thrilled to help take the medical device practice to the next level.”

The firm’s expansion of its medical device practice follows the firm’s expansion of its trademark practice at the end of 2018.

“FDA regulation and enforcement touches on almost everything we do,” said Ivan Wasserman, the firm’s Managing Partner. “We are so honored that Neil has joined us. Our firm, our medical device clients, and even our clients in other industries are going to benefit tremendously from his wealth of knowledge and experience in FDA matters.”