Post Market Surveillance for Class II Medical Devices

MikeKilkelly

Starting to get Involved
#1
Hi All,
Can someone please help me understand where FDA Post Market Surveillance requirements are for Class II devices are documented.

regards
Mike
 
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yodon

Staff member
Super Moderator
#2
As far as I know, the only regulation is 21 CFR 822 which is a mandated postmarket surveillance; i.e., the FDA calls up and says do this. Of course, with your normal risk management activities, you should be continually assessing postmarket data (complaints, AEs, similar products, etc.) to ensure your risk file is up to date and your device is meeting safety and performance requirements. I just don't think there are any specific reporting requirements (unless mandated). (There may be annual reports and such, I believe, but not like the CER or PSUR.)
 
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