The road to FDA clearance for medical devices may change radically in the next year.
Last summer, initial discussion began around implementing a pre-certification program for medical device companies, which would allow certain companies that the FDA has deemed responsible and safe in their development to build products without each new device undergoing the FDA clearance or approval process.
http://www.mobihealthnews.com/conte...orkshops-give-industry-and-agency-chance-talk
The road to FDA clearance for medical devices may change...
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