21 Cfr Medical Devices

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eCFR :: 21 CFR Chapter I Subchapter H

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 departments and agencies of the Federal Government. The Electronic Code of Federal Regulations (eCFR) is a continuously updated online version of the CFR.

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 …

21 CFR Subchapter H - MEDICAL DEVICES | CFR | US …

https://www.law.cornell.edu/cfr/text/21/chapter-I/subchapter-H

21 CFR Subchapter H - MEDICAL DEVICES. CFR. prev | next. PART 800 - GENERAL (§§ 800.10 - 800.75) PART 801 - LABELING (§§ 801.1 - 801.437) PART 803 - MEDICAL …

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPartFrom=800&CFRPartTo=1299

Medical device classification procedures: 861: Procedures for performance standards development: 862: Clinical chemistry and clinical toxicology devices: 864: …

eCFR :: 21 CFR Part 860 -- Medical Device Classification …

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-860

(b) A regulation or an order classifying or reclassifying a device into class I will specify which requirements, if any, of sections 510, 519, and 520(f) of the Federal Food, Drug, and …

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 …

eCFR :: 21 CFR 1.76 -- Medical devices.

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-D/section-1.76

( a) Registration and listing. For a medical device, the Registration Number for Foreign Manufacturers, Foreign Exporters, and/or Domestic Manufacturers, and the Device …

eCFR :: 21 CFR Part 880 -- General Hospital and …

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-880?toc=1

eCFR :: 21 CFR Part 880 -- General Hospital and Personal Use Devices eCFR The Electronic Code of Federal Regulations Title 21 Displaying title 21, up to date as of …

Device Labeling | FDA - U.S. Food and Drug Administration

https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling

Device Labeling Introduction to Medical Device Labeling Label vs. Labeling The U.S. Food and Drug Administration (FDA) develops and administers regulations …

SUBCHAPTER H—MEDICAL DEVICES

https://www.govinfo.gov/content/pkg/CFR-2022-title21-vol8/pdf/CFR-2022-title21-vol8-part800.pdf

SUBCHAPTER H—MEDICAL DEVICES PART 800—GENERAL Subpart A [Reserved] Subpart B—Requirements for Specific Medical Devices Sec. ... §800.12 21 CFR Ch. I …

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