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HHS - 21 CFR PART 822

POSTMARKET SURVEILLANCE

active
Organization: HHS
Publication Date: 1 April 2018
Status: active
Page Count: 9
scope:

What is the purpose of this part?

The purpose of this part is to implement our postmarket surveillance authority to maximize the likelihood that postmarket surveillance plans will result in the collection of useful data. These data can reveal unforeseen adverse events, the actual rate of anticipated adverse events, or other information necessary to protect the public health.

What does this part cover?

This part implements section 522 of the Federal Food, Drug, and Cosmetic Act (the act) by providing procedures and requirements for postmarket surveillance of class II and class III devices that meet any of the following criteria:

(a) Failure of the device would be reasonably likely to have serious adverse health consequences;

(b) The device is intended to be implanted in the human body for more than 1 year; or (c) The device is intended to be used outside a user facility to support or sustain life. If you fail to comply with requirements that we order under section 522 of the act and this part, your device is considered misbranded under section 502(t)(3) of the act and you are in violation of section 301(q)(1)(C) of the act.

Document History

April 1, 2020
POSTMARKET SURVEILLANCE
What is the purpose of this part? The purpose of this part is to implement our postmarket surveillance authority to maximize the likelihood that postmarket surveillance plans will result in the...
April 1, 2019
POSTMARKET SURVEILLANCE
What is the purpose of this part? The purpose of this part is to implement our postmarket surveillance authority to maximize the likelihood that postmarket surveillance plans will result in the...
21 CFR PART 822
April 1, 2018
POSTMARKET SURVEILLANCE
What is the purpose of this part? The purpose of this part is to implement our postmarket surveillance authority to maximize the likelihood that postmarket surveillance plans will result in the...
April 1, 2017
POSTMARKET SURVEILLANCE
What is the purpose of this part? The purpose of this part is to implement our postmarket surveillance authority to maximize the likelihood that postmarket surveillance plans will result in the...
April 1, 2016
POSTMARKET SURVEILLANCE
A description is not available for this item.
April 1, 2015
POSTMARKET SURVEILLANCE
What is the purpose of this part? The purpose of this part is to implement our postmarket surveillance authority to maximize the likelihood that postmarket surveillance plans will result in the...
April 1, 2014
POSTMARKET SURVEILLANCE
What does this part cover? This part implements section 522 of the Federal Food, Drug, and Cosmetic Act (the act) by providing procedures and requirements for postmarket surveillance of class II and...

References

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