GMP: FDA publishes Draft Guidance on Design of Medical Devices
31.01.2013
CDRH, the FDA department responsible, inter alia, for the regulation of medical devices, published a new draft guidance in mid-December 2012. The Guidance (\"Design Considerations for Devices Intended for Home Use\") aims at assisting manufacturers in developing and designing home use medical devices.
The source of the news: http://www.gmp-compliance.org/eca_news_3493_10319,7806,Z-VM.html
SciencePharma
