PL EN

GMP: FDA publishes Draft Guidance for Industry on Processing/Reprocessing Medical Devices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

kapitał ludzki

fundusz społeczny

Narodowe Centrum Badań i Rozwoju

innowacyjna gospodarka

rozwój regionalny