[Federal Register: February 18, 2005 (Volume 70, Number 33)]
[Page 8377-8378]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005D-0043]

Blood Pressure Measurement Devices (Sphygmomanometers)--Accuracy; 
Draft Revised Compliance Policy Guide; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft revised guidance for FDA staff and industry 
entitled ``Compliance Policy Guide (CPG) Sec. 310.210 Blood Pressure 
Measurement Devices (Sphygmomanometers)--Accuracy (CPG 7124.23).'' This 
draft CPG provides guidance concerning accuracy and exhaust rate 
criteria for sphygmomanometers. This draft guidance is being issued for 
public comment only and will not be implemented until a final CPG is 
announced in the Federal Register.

DATES: Submit written or electronic comments on the draft guidance by 
May 19, 2005.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Compliance Policy (HFC-230), Office of 
Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, or FAX your request to 240-632-6861. Submit 
written comments on the draft guidance to the Division of Dockets 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.


[[Page 8378]]

for electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Jeffrey B. Governale, Division of 
Compliance Policy (HFC-230), Office of Enforcement, Office of 
Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 240-632-6851.


I. Background

    In 1992 and 1994, the Association for the Advancement of Medical 
Instrumentation (AAMI) issued two revised standards that were approved 
by the American National Standards Institute (ANSI) namely, ``ANSI/AAMI 
SP9-1994 American National Standard Non-Automated Sphygmomanometers'' 
and ``ANSI/AAMI SP10-1992 American National Standard for Electronic or 
Automated Sphygmomanometers.''
    As amended by the FDA Modernization Act of 1997 (FDAMA), section 
514(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d(c)) 
allows FDA to recognize consensus standards, established by 
international and national standard development organizations, for use 
in satisfying portions of device premarket review submissions or other 
requirements. FDA now recognizes the complete standards ANSI/AAMI SP9-
1994 and ANSI/AAMI SP10-1992 for the purpose of premarket clearance (63 
FR 55617, October 16, 1998; 67 FR 1774, January 14, 2002). To be 
consistent with current industry practice, FDA intends to use the 
accuracy and exhaust rate criteria identified in these recognized 
consensus standards as guidance for testing, surveillance, and 
compliance purposes, as well as for premarket clearance. Therefore, 
this draft revised guidance reflects the accuracy and exhaust rate 
criteria in the currently recognized revisions of these two voluntary 

II. Significance of Guidance

    This draft guidance represents the agency's current thinking on 
this topic. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statutes and regulations.
    In accordance with FDA's good guidance practices regulation (21 CFR 
10.115), this draft document is considered a level 1 guidance. This 
draft guidance is being issued for public comment only and is not in 
effect at this time. Only after a notice of availability is published 
in the Federal Register for the final document will the agency 
implement the guidance.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. The agency will review all comments, 
but in issuing final guidance, need not specifically address each 
comment. If appropriate, the agency will make changes to the guidance 
in response to comments. The draft guidance and received comments may 
be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora/compliance_ref/revisions.htm.

    Dated: February 10, 2005.
John Marzilli,
Acting Associate Commissioner for Regulatory Affairs.
[FR Doc. 05-3116 Filed 2-17-05; 8:45 am]