R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.


New Biocompatibility Draft Guidance

FDA issued a new draft guidance document on biocompatibility on Tuesday April 23, entitled Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. It is intended to replace the ODE General Program Memorandum #G95-1. G95-1 was issued in 1995 in the span of 18 years a lot has changed regarding FDA’s view on biocompatibility.

FDA issues draft guidance for accurate labeling on medical products that are not made with natural rubber latex

What do adhesive bandages, blood-pressure monitoring cuffs, sanitary napkins, ventilator bellows, wheel chair cushions, and dental dams all have in common?

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