EXTRACTABLES AND LEACHABLES FOR MEDICAL DEVICES: MEETING THE 510 (k) REQUIREMENTS

Kurt Moyer, Ph.D.
Director of Research, NSF Pharmalytica
Bristol, Connecticut, USA 06010

BIOGRAPHICAL NOTE
Dr. Moyer is currently the Director of Research at NSF Pharmalytica. Prior to joining NSF Pharmalytica, Dr. Moyer served as a Senior Research Investigator for Sanofi Aventis and a Research Scientist for the DuPont Pharmaceutical Company. Dr. Moyer has more than 20 years of pharmaceutical development experience spanning all areas from discovery support to Phase III. Dr. Moyer holds a Ph.D. in Biochemistry from Villanova University and a BS in Biochemistry from Millersville State University.

ABSTRACT
Recent changes in the FDA’s 510(k) requirements for medical device applications have spawned many inquiries from clients on how to address the request for extractables, leachables and drug compatibility data. Meeting the expectations of the CDRH can be challenging in that any given study design is not universally applicable to all devices. A good study design requires elements of the best practices documented in ISO-10993-12, the PQRI guidance for E&L testing of OINDP as well as any specific requests for drug compatibility data from CDRH.

A hybridized study design, incorporating the essential regulatory elements, has been developed and successfully implemented for a variety of medical device applications. The rationale behind selection