Pearl Pathways invites you to look over a final guidance just released by the FDA Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.” This encourages medical device manufacturers to first start with a risk assessment to determine if new biocompatibility testing is required for premarket submissions. It also explains new test-specific recommendations to follow.
The FDA is also holding a free webinar on July 21, 2016 discussing this final guidance. Click here for information on how you can dial-in to hear the presentation and also ask questions. Registration is not necessary.
Pearl Pathways’ experienced team is ready to assist your product development team with your biocompatibility evaluations. Contact us to be your partner in accelerating your product development regulatory pathways.