FDA常用網(wǎng)址查詢

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases

2.FDA官方指南

https://www.fda.gov/regulatory-information/search-fda-guidance-documents

3.510K K號(hào)查詢（含代理公司批準(zhǔn)數(shù)量查詢）

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

4.PMA 查詢

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm

5.FDA產(chǎn)品分類查詢

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm

6.FDA企業(yè)注冊(cè)和產(chǎn)品列名

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

7.UDI公眾查詢數(shù)據(jù)庫

https://accessgudid.nlm.nih.gov/

8.MAUDE database（制造商數(shù)據(jù)庫）

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM

9.Import Alerts （進(jìn)口警報(bào)）

https://www.fda.gov/industry/actions-enforcement/import-alerts

10.FDA's Recalls  （FDA的召回）

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm

11.483和警告信

https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/default.htm

12.Class I / II Exemption （ FDA 豁免的I類和II類設(shè)備）

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051549.htm

13.Medical Device Exemptions （510(k) 豁免目錄 ）

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm‍

14.FDA MDSAP

https://www.fda.gov/medical-devices/cdrh-international-programs/medical-device-single-audit-program-mdsap

15.DMF

https://www.fda.gov/drugs/forms-submission-requirements/drug-master-files-dmfs

16 .eCTD

https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd

17.OTC -Over The Counter

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfIVD/Search.cfm

18.FDA IVD法規(guī)

https://www.fda.gov/medical-devices/ivd-regulatory-assistance/overview-ivd-regulation

19.FDA 藥物濫用檢測(cè)

https://www.fda.gov/medical-devices/in-vitro-diagnostics/drugs-abuse-tests