Recent changes in the FDA’s 510(k) requirements for medical devicses has lead to confusion 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.

Pine Lake Laboratories has 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 of the elements, overall experimental design strategy and interpretation of the resulting are available in the technical library.

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