21 Cfr 820 Medical Devices

eCFR :: 21 CFR Part 820 -- Quality System …

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820

(a) Each manufacturer shall establish and maintain procedures for control and distribution of finished devices to ensure that only those devices approved for release are distributed and that purchase orders are reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution. Where a device's fitness for use or quality deteriorates over time, the procedures shall ensure that expired devices or devices deteriorated beyond acceptable fitness for use are ...

CFR - Code of Federal Regulations Title 21 - Food and …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=820

CFR - Code of Federal Regulations Title 21 FDA Home Medical Devices Databases The information on this page is current as of Jul 20, 2022. For the most up-to …

Quality System (QS) Regulation/Medical Device Good …

https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices

eCFR :: 21 CFR Chapter I Subchapter H -- Medical Devices

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H

The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the …

CFR - Code of Federal Regulations Title 21 - Food and …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=820&showFR=1

Manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps), as defined in § 1271.3(d) of this chapter, that are medical devices …

Medical Devices; Current Good Manufacturing Practice …

https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices/medical-devices-current-good-manufacturing-practice-cgmp-final-rule-quality-system-regulation

CGMP requirements for devices in part 820 (21 CFR part 820) were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(f)), …

Medical Devices; Quality System Regulation …

https://www.fda.gov/media/160124/download

FDA published the proposed amendment to 21 CFR Part 820: Medical Devices; Quality System Regulation Amendments, on February 23, 2022; harmonizing the current Quality …

eCFR :: 21 CFR 820.181 -- Device master record.

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-M/section-820.181

§ 820.181 Device master record. Each manufacturer shall maintain device master records (DMR's). Each manufacturer shall ensure that each DMR is prepared and approved in …

eCFR :: 21 CFR Part 803 -- Medical Device Reporting

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-803

(j) Importer means any person who imports a device into the United States and who furthers the marketing of a device from the original place of manufacture to the person who …

eCFR :: 21 CFR Part 821 -- Medical Device Tracking …

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-821

(f) Device intended to be implanted in the human body for more than 1 year means a device that is intended to be placed into a surgically or naturally formed cavity of …