GMP,ICH,Healthcare,Inspection Focus,Compliance,Ste 2012 - Live webinar on Understanding FDA Expectations for Reusable Medical Devices By Compliance2go
Date ： 2012-08-16 Deadline： 2012-08-16
Venue： houston / USA
Keywords： Compliance Processes ,Life Science ,Clinical Trials,Registrations, Renewals,Supply Chain ,Licensing Products,Innovative Drugs,Generics,Similars,Vaccines,Packaging,
Update： 2012-07-04 02:08:35
Topics/Call fo Papers
The U.S. Food and Drug Administration’s (FDA) expectations on the development and validation of reprocessing/processing instructions for reusable medical devices and user-sterilized single use devices is changing and evolving. This is also true of FDA’s expectations on how to properly validate the reprocessing/processing methods reflected in the instructions. FDA also has expectations for healthcare facilities which carry out such reprocessing/processing. Having proper reprocessing/processing instructions can be crucial to obtaining FDA clinical study or marketing approval/clearance for your device. Learn about FDA’s latest expectations in this area so you can optimize your chances of success in dealing with FDA on clinical study and marketing applications and to avoid FDA compliance problems.
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
60 Minutes Live Presentation
Description of the Topic:
According to FDA, there have been notable advances in recent years in the knowledge and technology related to reprocessing/processing reusable and user-sterilized single use medical devices. There also has been an evolution towards more complex devices which have designs that are more difficult to clean and disinfect or sterilize. FDA feels the need to update its expectations and recommendations to account for these changes. In furtherance of this, FDA issued a draft guidance in May 2011 entitled “Guidance for Industry and FDA Staff; Processing/Reprocessing Medical Devices in Healthcare Settings: Validation Methods and Labeling.” The draft guidance provides updated expectations and recommendations for developing and validating reprocessing/processing instructions and for validating the reprocessing/processing methods described in the instructions. The seminar will summarize and discuss the implications of FDA’s updated expectations and recommendations, as described in the draft guidance.
Who will benefit:
Representatives of manufacturers, marketers and users of reusable medical devices and user-sterilized single use devices, including in-house counsel, outside FDA counsel, regulatory affairs personnel, and regulatory consultants.
Mr. O'Flaherty is a principal with the firm and concentrates his practice in the area of FDA regulation of medical devices. He has spoken domestically and internationally and written extensively on device and other FDA-related topics, including: FDA regulation of in vitro diagnostics, blood bank software and human cell and tissue products; FDA inspectional and enforcement authority; FDA clinical trial requirements; FDA regulatory obligations of hospitals; and the impact of FDA law on business transactions and agreements. Over the years, Mr. O'Flaherty's device work has included assistance to the Advanced Medical Technology Association (AdvaMed), the nation's largest trade association for the medical device industry, including assistance on device tracking, medical software, and device reclassification matters. His practice also includes legal matters relating to other FDA-regulated products.
Mr. O'Flaherty was born in Chicago, Illinois and received his B.A. with honors in 1987 from University of Notre Dame and his J.D. from Loyola University of Chicago School of Law in 1990. He was admitted to the Illinois Bar in 1990 and the District of Columbia Bar in 1991. Mr. O'Flaherty is currently a member of the District of Columbia Bar and the Illinois and American Bar Associations. He is also a member of the American Health Lawyers Association.
Mr. Terman is a principal at OFW Law. He was born in Washington, DC, and received his B.S. in economics in 1973 from the University of Maryland where he was Phi Kappa Phi and his J.D. in 1976, also from the University of Maryland. Mr. Terman was admitted to the Maryland Bar in 1976 and the District of Columbia Bar in 1979. He is currently a member of the District of Columbia Bar