Biocompatibility assessments for medical devices – evolving regulatory considerations

ABSTRACT

Introduction: Biocompatibility assessment provides key data supporting medical device development and marketing. Although regional and international guidance is available, differences in proposed biocompatibility assessments or test methods lead to confusion and inefficiencies in generating the package of supporting nonclinical data.

Areas covered: Modifications to available guidance for biological safety testing of medical devices, as described by the International Organisation for Standardisation (ISO) and the US Food and Drug Administration (FDA), have, over time, sometimes increased and sometimes decreased the level of harmonisation in testing requirements. These requirements continue to evolve, as shown by refinements and supplements to existing ISO 10,993 standards, new ISO standards under development and new finalised guidance from the FDA – which shows a shift away from routine testing-based approaches and much greater emphasis on characterisation, with use of existing literature or demonstration of equivalence to established comparator products, where possible.

Expert commentary: This article examines the impact of recent changes in guidance for biocompatibility assessment of new medical devices and shows that, although a high level of consistency now occurs in ISO and FDA requirements, there are still areas where a ‘standard approach’ is not possible, allowing hurdles for global development of medical devices to persist.

KEYWORDS:

• Biocompatibility
• biological evaluation
• biological safety
• medical device
• non-clinical testing

Declaration of interest

L. Reeve and P. Baldrick are employed by Covance Inc. within the Global Strategy Group. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

This paper was not funded.