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Code of Federal Regulations (CFR) is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas subject to Federal regulation.
21 CFR[]
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP).[1]
The 800 series are for medical devices:
- 803 Medical Device Reporting
- 21CFR 803.1 (reporting adverse events) - a) This part establishes the requirements for medical device reporting for device user facilities, manufacturers, importers, and distributors. If you are a device user facility, you must report deaths and serious injuries that a device has or may have caused or contributed to, establish and maintain adverse event files, and submit summary annual reports. If you are a manufacturer or importer, you must report deaths and serious injuries that your device has or may have caused or contributed to, you must report certain device malfunctions, and you must establish and maintain adverse event files. [2][3]
- 814 Premarket Approval of Medical Devices [4]
- 820 et seq. Quality system regulations (analogous to current good manufacturing practice, but structured like International Organization for Standardization) [5]
- 821 Medical Device Tracking requirements.
- Sec. 821.30 Tracking obligations of persons other than device manufacturers: distributor requirements.[6]
- 860 et seq. Listing of specific approved devices and how they are classified
- 872 Dental Devices
- 872.1720 - Pulp tester.
- 872.1800 - Extraoral source x-ray system.
- 872.1810 - Intraoral source x-ray system.[7]
- 886 Opthalmic Devices
- 886.1140 - Ophthalmic chair.
- 886.1170 - Color vision tester.
- 886.1700 - Pupillometer.
- 898 Performance Standard Electrode Lead Wires and Patient Cables.
- 900 series covers mammography quality requirements enforced by Center for Devices and Radiological Health (CDRH).
- 1000 series covers radiation-emitting device (e.g. cell phones, LASERs, x-ray generators); requirements enforced by the Center for Devices and Radiological Health.
- 1000.55 - Recommendation for quality assurance programs in diagnostic radiology facilities. (i.e. x-ray)
- 1000.15 - Examples of electronic products subject to the Radiation Control for Health and Safety Act of 1968. (i.e. LASER)
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References[]
- ↑ CFR Title 21. US FDA. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm accessdate= February 2014
- ↑ FDA, 21 CFR: Sec. 803.1 What does this part cover? http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=803.1 accessdate 6/16/15
- ↑ FDA, 21 CFR: Subpart C--User Facility Reporting Requirements http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=803.30 accessdate 6/16/15
- ↑
- ↑
- ↑ FDA, 21 CFR: Subpart C--Additional Requirements and Responsibilities http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=821.30 accessdate 6/16/15
- ↑ FDA, 21 CFR: PART 872 - Dental Devices http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm accessdate 6/16/15