|James M. Flaherty, Jr.|
BALTIMORE — On Friday, Feb. 24, O&P practitioners, manufacturers and distributors gathered here for the first annual US Food and Drug Administration (FDA) Compliance Seminar hosted by the American Orthotic and Prosthetic Association (AOPA). The goal of the seminar was to provide professionals with the tools and information to better understand the role of the FDA in O&P. As the FDA seeks to more strongly assert their authority, O&P professionals must understand the guidelines and numerous gray areas inside FDA regulations.
In the morning session, James M. Flaherty, Jr., JD, registered patent attorney with Foley Hoag LLP, reviewed the FDA’s authority, as well as led a discussion detailing which regulations apply to O&P patient care facilities, manufacturers and distributors. Also in the morning session, Larry R. Pilot, Esq., reviewed good manufacturing practices (GMPs) and the keys to compliance with FDA investigators.
|Thomas F. Fise|
In the afternoon session, Pilot, a former government official with years of litigation experience assisting businesses in their efforts to comply with FDA enforcement activities, gave the audience unique insight into how to prepare for and manage inspections conducted by FDA investigators. Later in the afternoon session, Flaherty led a discussion on how the FDA defines “custom devices,” sparking an open discussion with the audience. Stephen Carr, Esq., executive director and general counsel for Otto Bock HealthCare North America, spoke in the afternoon session detailing how new FDA initiatives on 510(k)s could affect O&P. Leslie Pitt Schneider, JD, RN, manager for clinical and regulatory affairs, Otto Bock HealthCare, reviewed the FDA’s proposed unique device identification rule and its potential impact on the O&P profession now and in the future.
“I think that we covered a lot of new ground for O&P professionals,” Thomas F. Fise, executive director, AOPA, told O&P Business News at the seminar. “There are many people that would have benefitted from being here and I wish we can bring this to others. We are going to have this as a continuing challenge and focal point.”
O&P Business News will provide more coverage of this event in a future issue.