Market Vigilance and Oversight of Devices

Just as with drugs, market vigilance systems are required to ensure that problems with devices are identified and addressed in a timely manner. Although they share 

Periodic adverse Every 3 months for the first Summary and analysis of all adverse 

21 CFR 600.80 (c) 2 incidents History of actions taken in response to incidents 

Distribution report - Every 6 months Distribution data 

Annual Report Annually Summary of significant information 

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Market Vigilance and Oversight of Devices 263 Table 12.3 Su mmary of periodic reporting obligations 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. 

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