Revised Guidance Advises on Use of ISO 10993-1 for Device Biocompatibility

In a new final guidance “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process’”, the FDA provides information on using ISO 10993-1 for evaluating devices that come into direct contact with intact skin, including the types of information that should be included in premarket submissions.
Source: Drug Industry Daily