[ RadSafe ] Fwd: CDRH Industry: Radiation Biodosimetry Medical Countermeasure Devices - Guidance for Industry and FDA Staff

[Tim Hart]

All,

I found this  an interesting read, although I though most of it was pretty
standard fair. The U.S. Food and Drug Administration has issued a guidance
titled, Radiation Biodosimetry Medical Countermeasure Devices
<http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbXNpZD0mYXVpZD0mbWFpbGluZ2lkPTIwMTYwNDE4LjU3OTIxNDYxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE2MDQxOC41NzkyMTQ2MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3NjcwNDI2JmVtYWlsaWQ9bWFnc3BpZHlAZ21haWwuY29tJnVzZXJpZD1tYWdzcGlkeUBnbWFpbC5jb20mdGFyZ2V0aWQ9JmZsPSZleHRyYT1NdWx0aXZhcmlhdGVJZD0mJiY=&&&100&&&http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM427866.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery>.
FDA has developed this guidance to provide industry and Agency staff with
recommendations for the types of information that should be submitted to
support marketing authorization (e.g., clearance or approval) for radiation
biodosimetry medical countermeasure devices. This guidance applies to
premarket submissions for medical device systems intended to measure
biological responses to unintended (non-therapeutic) radiation absorption.

The address for the guidance is
http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbXNpZD0mYXVpZD0mbWFpbGluZ2lkPTIwMTYwNDE4LjU3OTIxNDYxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE2MDQxOC41NzkyMTQ2MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3NjcwNDI2JmVtYWlsaWQ9bWFnc3BpZHlAZ21haWwuY29tJnVzZXJpZD1tYWdzcGlkeUBnbWFpbC5jb20mdGFyZ2V0aWQ9JmZsPSZleHRyYT1NdWx0aXZhcmlhdGVJZD0mJiY=&&&100&&&http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM427866.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery


-- 
Tim Hart