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CDG's Biological Safety Rescue Squad

Medical Device Biological Safety
The biocompatibility of medical devices is approached differently in the States than it is in Europe. FDA prefers a data-based approach. Europe prefers a literature-based defense. In either case, following the ISO 10993 or ISO 10993/G95 matrixes is only a beginning; the data supporting the biological safety of the final device must give ‘reasonable assurance’ of its safety in real use situations. You need to play ‘devil’s advocate’; thinking of all the ways your device might cause a biological reaction with the body and then address each possibility with data, proposed labeling, and a plan for mitigation.

For example, FDA raised the question if an implanted material might have a local oxidative effect. The question required the design of a unique animal test and a focused literature search reviewing the chemistry of the materials. In another example, FDA wanted to know the concentration of unreacted monomers, bimers, and trimers to the ppb level in a plastic, the analytical testing required a unique design. In a third example, reviewers wanted to know the possibility of an implanted material injuring a nerve, the solution required a sub-chronic test in which devices were implanted in dogs.

Clinical Device Group’s Rescue Squad

Your first contact with Clinical Device Group will be with Nancy J Stark, PhD. With a doctorate in biochemistry, Dr. Stark will assess your biological safety questions and determine if the firm is able to help you. She will answer your initial questions about the company, its history, services, and rates; will sign a confidentiality agreement and negotiate a service agreement with you. Once the administrative end of the relationship is in place, you’ll be referred to our primary toxicologist, Dr. Daniel McLain.

The Expert Himself

Next you’ll be referred to Dr. Daniel McLain, MS/PhD, Nutritional Toxicology and Preventive Medicine, who will begin immediately to assess your issues and recommend strategies and solutions. He may recommend a literature review, he may provide expert interpretations of laboratory reports, he may recommend additional testing at the test house of your choosing, he may assist in writing unique protocols for sub-chronic or chronic tests, or he may provide expert justifications of safety based on the data you have now. Dan can prepare risk assessments, preclinical strategies, or prepare the biological safety sections of 510(k)s, PMAs, or BLAs.

Dr. McLain is an internationally recognized toxicologist in the medical device industry and currently serves as the Convener for ISO 10993: Biological evaluation of medical devices – Part 11: Systemic toxicity evaluation. It is an extreme honor to serve as a convener, because it is a nomination of your peers, recognizing your expertise in the technical area and ability to work with people to bring them to consensus. He has had extensive interaction with global regulatory bodies as it pertains to product safety submissions and is held in high regard for his development strategies and commitment to product safety.

Now for Some Fun

First, click here to solve the puzzle of biological safety on the right.

Second, take Poll du jour 6, a 30-second quiz about FDA's views on biological safety and see how your answers compare to others.

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Clinical Device Group Inc
773-489-5721
mailto: cdginc@clinicaldevice.com

NJ Stark