White Paper: Research Lab

Understanding Medical Device Extractable and Leachables Testing in 2020


The world of physics has a foundation built on beautiful universal constants that work their way steadfastly into the equations governing electrodynamics, and then further extend themselves into our hands in the design of smart interconnected electrical devices that are commonplace to modern life.

Ironically, universal constants form the founda¬tion of life for which it is popularly said that the only constant is change. This constancy of change is also very well proven in the world of medical device regulation, perhaps especially with respect to biocompatibility and how chemical information fits into that puzzle.

Over the past five years, the medical device community has swung from nearly full ignorance of the potential power of chemistry testing, to full acceptance, and now back to a state of scrutiny. As medical device chemistry for toxicology (ChemTox) has matured, the overall strategy has changed dramatically on some points.

The term “extractables and leachables” for medical devices is an adaptation of the same term that has been applied to pharmaceutical container/closure systems. However, for patient contacting medical devices, a true leachables study is impossible because the device leaches into the body – not a drug. Using a definition commonly applied in ISO 10993 for other tests, regulators require that extractables studies are conducted exhaustively.

This white paper details medical device ChemTox study data and how Nelson Labs is committed to frequent and transparent communication and guidance on the subject to its customers and the FDA.

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