Medical Device Vigilance in the US

The requirements for market vigilance and oversight in the US are set out in 21 CFR 803, Medical Device Reporting, 21 CFR 806, Reports of Corrections and Removals and 21 CFR 822 Post market Surveillance. 

Commercial name of the affected product FSCA-identifier (e.g. date) 

Type of action (e.g. Refer to definition of a FSCA in MEDDEV 2.12/1) 

Specific details to enable the affected product to he easily identified e.g. type of device, model name and number, batch/ serial numbers of affected devices and part or order number. 

A factual statement explaining the reasons for the FSCA, including description of the device deficiency or malfunction, clarification of the potential hazard associated with the continued use of the device and the associated risk to the patient, user or other person. 

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