My recent work has involved providing regulatory assistance to software medical devices. One thing I have been learning about is how security and privacy is handled with these types of products. Often times I have experienced clients grouping regulatory affairs with privacy and security. Project teams have looked to the regulatory engineers for guidance on how to handle privacy and security of patient data used within the software. This was a new area of focus for me. In my research on privacy and security I looked a lot to internal experts on these to subjects, in addition the FDA has issued a draft guidance titled Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
FDA issued a new draft guidance document on biocompatibility on Tuesday April 23, entitled Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation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.