EN PL

GMP: FDA publishes Draft Guidance for Industry on Processing/Reprocessing Medical Devices

06.07.2011
The aim of the new Guidance is to inform reviewers - in the premarket application process for medical devices (510k, PMA, HDE processes) and for clinical studies (IDE process) - about the latest developments and support them during the review process. Moreover, the draft deepens the process validation topic in the context of reprocessing.