Past Meetings

Changes in the FDA Approval Process and Oversight of the Re-Use of DisposablesBack

05/19/2006

Our May meeting focused primarily on a facilited discussion of the FDA's policies, procedures, and systems, especially as they affect the provider and information technology sectors. 
As our speakers, we were fortunate to have Becker & Associates Consulting, Inc., a leading scientific and FDA regulatory consulting firm located in Washington DC. The company specializes in the FDA regulation of innovative healthcare products, and provides services to healthcare companies and their counsel that assist in gaining FDA approval and managing post-marketing issues. (See below for power point presentation)
Karen Becker and Phil Phillips led the discussion and presented information to the group on the following issues, among others:
-Understanding the philosophical ideas behind the FDA's approaches to its oversight responsibilities. Why do they do it this way, and what forces have an impact on how they operate?
-What are current critical issues for industry, the public, and FDA in the drug and medical device approval process? 
-Will hospital information systems and clinical information systems move into the "device" category and become subject to the validation process (similar to monitoring systems and RF based IV drug dispensing systems)? 
The core competencies of Becker & Associates are FDA Regulation of Drugs, Medical Devices, and Cosmetics; Economic Analyses and Strategic Reimbursement; and Litigation Support and Expert Testimony. Dr. Karen M. Becker is founder and President of the firm, and manages the Pharmaceutical Practice for the company. She has 20 years of experience in the field. Mr. Philip J. Phillips is Director of the Medical Device Practice, having served for 24 years at FDA in the Center for Devices and Radiological Health, most recently as Deputy Center Director.
Mark Fehling, now an industry consultant and previously CIO at George Washington University Hospital, helped organize this meeting and assisted in the presentations and discussions.