基本信息
文件名称：21 CFR Part 822 (up to date as of 10-15-2024)&21 CFR Part 830 (up to date as of 10-15-2024)二零二四年十月十五.pdf
文件大小：221.6 KB
总页数：26 页
更新时间：2025-05-24
总字数：约8.13万字
文档摘要

21CFRPart822(uptodateasof10/15/2024)

21CFRPart822(Oct.15,2024)

PostmaretSurveillance

ThiscontentisfromtheeCFRandisauthoritativebutunofficial.

Title21—FoodandDrugs

ChapterI—FoodandDrugAdministration,DepartmentofHealthandHumanServices

SubchapterH—MedicalDevices

21CFRPart822(Oct.15,2024)(enhanceddisplay)page1of14

21CFRPart822(uptodateasof10/15/2024)

21CFRPart822(Oct.15,2024)

PostmaretSurveillance

Part822PostmarketSurveillance

SubpartAGeneralProvisions

§822.1Whatdoesthispartcover?

§822.2Whatisthepurposeofthispart?

§822.3Howdoyoudefinethetermsusedinthispart?

§822.4Doesthispartapplytome?

SubpartBNotification

§822.5HowwillIknowifImustconductpostmarketsurveillance?

§822.6WhenwillyounotifymethatIamrequiredtoconductpostmarketsurveillance?

§822.7WhatshouldIdoifIdonotagreethatpostmarketsurveillanceisappropriate?

SubpartCPostmarketSurveillancePlan

§822.8When,where,andhowmustIsubmitmypostmarketsurveillanceplan?

§822.9WhatmustIincludeinmysubmission?

§822.10WhatmustIincludeinmysurveillanceplan?

§822.11WhatshouldIconsiderwhendesigningmyplantoconductpostmarketsurveillance?

§822.12Doyouhaveanyinformationthatwillhelpmepreparemysubmissionordesignmy

postmarketsurveillanceplan?

§822.13[Reserved]

§822.14MayIreferenceinformationpreviouslysubmittedinsteadofsubmittingitagain?

§822.1