GMP: FDA publishes Draft Guidance for Industry on Processing/Reprocessing Medical Devices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.
The source of the news: http://www.gmp-compliance.org/eca_news_2638_7128,6971,6979.html
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