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FDA proposes changes to biological review of medical devices

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English: Logo of the . (Photo credit: Wikipedia)

The FDA has issued draft guidance intended to help companies prepare regulatory submissions for devices that come into contact with the human body directly or indirectly.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.

View Full Article in: Clinica (subscription required)
 
 
 
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