Case Study 4

Case Study 04: Extractables and Leachables Testing for PMA Medical Device


Project Objectives

Enable Life Sciences was engaged by a US-based Medical Devices company to lead Extractables and Leachables testing for the company’s PMA (Pre Market Approval) implantable medical device, and answer a formal question (posed to the medical devices company) by the US FDA (Food and Drug Administration)

Execution of Project

In executing on the project objectives, Enable Life Sciences:

·      Led detailed internal discussions at the medical devices company to comprehensively interpret the FDA question and facilitated translation of the question into an action plan for analytical testing

·      Created a Request for Proposal (RFP) for the Analytical testing effort required for the Extractables and Leachables testing

·      Evaluated a short list of US-based service Contract service providers for the Extractables and Leachables testing, and recommended one to the client based on site visits

·      Created the legal agreement framework for the testing to be initiated (in coordination with the client’s legal resources)

·      Led the project management efforts for the Extractables and Leachables testing carried out by the chosen contract lab, in coordination with the client’s R&D and Regulatory leadership

·      Led the documentation (comprehensive reports) of the analytical results and created a data-driven framework to answer the question posed by the FDA

Concrete Project Outcomes

In a period of a few months, Enable Life Sciences was able to deliver concrete results for the medical devices client. These included (a) planning and creating an analytical frame of reference to answer the FDA question (b) executing and overseeing the testing with the appropriate analytical methodology, and (c) documentation of the results in the context most relevant to answering the question posed by the FDA