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CPG Sec. 310.210 Blood Pressure Measurement Devices (Sphygmomanometers) - Accuracy

Draft Guidance for FDA Staff and Industry

Document Release Date: February 18, 2005

U.S. Department of Health and Human Services
Food and Drug Administration
Office of Regulatory Affairs
Office of Enforcement
Division of Compliance Policy

Contains Nonbinding Recommendations



Public Comment:

Interested persons may submit written comments regarding this document to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/RegulatoryInformation/Dockets/Comments/default.htm. For questions regarding the use or interpretation of this guidance, contact Jeffrey Governale at 240-632-6851.

Additional Copies:

Submit written requests for a single copy of this guidance to the Division of Compliance Policy (HFC-230), Office of Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-001, or FAX your request to 240-632-6861. A copy of the guidance may also be downloaded to a personal computer with access to the Internet. The Office of Regulatory Affairs’ home page includes the guidance and may be accessed at http://www.fda.gov/ ICECI/ ComplianceManuals/ CompliancePolicyGuidanceManual/default.htm