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FDA has issued a final guidance on Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”. 

The document, issued on June 16th, can be accessed through the following link:

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm348890.pdf

There will also be a webinar on the final guidance on July 21, 2016. It will take place from 1:00 -2:30 PM, Eastern Time. For more information use the following link:

http://www.fda.gov/medicaldevices/newsevents/workshopsconferences/ucm507235.htm