The FDA has issued draft guidance intended to help companies prepare regulatory submissions for devices that come into contact with the human body directly or indirectly. The guidance, which is up for comment until July 22, outlines changes to how the international standard ISO-10993 should be used to identify possible toxicity issues tied to those devices.
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- What’s behind the FDA’s push for more patient engagement (hint: it’s not that everyone else is doing it) (medcitynews.com)
- Debate: The FDA’s Caution Is Hazardous To Our Health (fora.tv)
- FDA Wants To Increase Budget By Nearly $1 Billion, 94% Coming From Drug Industry – 11 May 2013 (lucas2012infos.wordpress.com)
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- If Tanning Beds Were a Drug, They’d Be Illegal (forbes.com)