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Title 21

Displaying title 21, up to date as of 7/16/2026. Title 21 was last amended 7/09/2026.
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Title 21Food and DrugsPart / Section
Chapter IFood and Drug Administration, Department of Health and Human Services1 – 1299
Subchapter HMedical Devices800 – 898
Part 822Postmarket Surveillance822.1 – 822.38
Subpart AGeneral Provisions822.1 – 822.4
§ 822.1What does this part cover?
§ 822.2What is the purpose of this part?
§ 822.3How do you define the terms used in this part?
§ 822.4Does this part apply to me?
Subpart BNotification822.5 – 822.7
§ 822.5How will I know if I must conduct postmarket surveillance?
§ 822.6When will you notify me that I am required to conduct postmarket surveillance?
§ 822.7What should I do if I do not agree that postmarket surveillance is appropriate?
Subpart CPostmarket Surveillance Plan822.8 – 822.15
Subpart DFDA Review and Action822.16 – 822.23
Subpart EResponsibilities of Manufacturers822.24 – 822.28
§ 822.24What are my responsibilities once I am notified that I am required to conduct postmarket surveillance?
§ 822.25What are my responsibilities after my postmarket surveillance plan has been approved?
§ 822.26If my company changes ownership, what must I do?
§ 822.27If I go out of business, what must I do?
§ 822.28If I stop marketing the device subject to postmarket surveillance, what must I do?
Subpart FWaivers and Exemptions822.29 – 822.30
§ 822.29May I request a waiver of a specific requirement of this part?
§ 822.30May I request exemption from the requirement to conduct postmarket surveillance?
Subpart GRecords and Reports822.31 – 822.38