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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Draft Guidance for FDA Staff and Industry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

DRAFT

Preface

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