[Federal Register: October 28, 2003 (Volume 68, Number 208)]
[Notices]
[Page 61446]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28oc03-63]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 1994N-0418]
Medical Devices; Reclassification of Automated External
Defibrillators
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of intent.
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SUMMARY: The Food and Drug Administration (FDA) announces an
opportunity to submit information and comments concerning FDA's intent
to initiate a proceeding to reclassify automated external
defibrillators (AEDs) from class III (premarket approval) to class II
(special controls). AEDs are devices that deliver an electric shock to
correct an arrhythmia.
DATES: Submit written or electronic information or comments by January
26, 2004.
ADDRESSES: Submit written comments 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
.
FOR FURTHER INFORMATION CONTACT: Megan Moynahan, Center for Devices and
Radiological Health (HFZ-450), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-443-8517, ext. 180.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of August 14, 1995 (60 FR 41984 and 41986),
FDA published two orders for certain class III devices requiring the
submission of safety and effectiveness information in accordance with
the preamendments class III strategy for implementing section 515(i) of
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(i))
(FDA published two updated orders in the Federal Register of June 13,
1997 (62 FR 32352 and 32355)). The orders describe in detail the format
for submitting the type of information required by section 515(i) of
the act so that the information submitted would either support
reclassification or indicate that a device should be retained in class
III. The orders also scheduled the required submissions in groups, at
6-month intervals, beginning on August 14, 1996. Arrhythmia detectors
and alarms, which included AEDs, were among the devices for which
information was to be submitted.
In response to this document, FDA received three petitions to
reclassify arrhythmia detectors and alarms from the following
petitioners: (1) Health Industry Manufacturers Association (HIMA) (now
known as Advamed), (2) Quinton Instrument Co., and (3) Zymed Medical
Instrumentation. The Advamed petition also requested reclassification
of AEDs. Additionally, Datascope Corp., Hogan and Hartson L.L.P., Life
Sensing Instrument Co., Medical Data Electronics, Inc., Mennen Medical
Ltd., Mortara Instrument, Inc., and Olsson, Frank, and Weeda, P.C.
submitted safety and effectiveness information (515(i) submissions).
In the Federal Register of December 13, 2002 (67 FR 76706), FDA
proposed to reclassify arrhythmia detector and alarm devices from class
III to class II. These devices are used to monitor an electrocardiogram
and to produce a visible or audible signal or alarm when an atrial or
ventricular arrhythmia exists. FDA also proposed to separate AEDs from
the identification of the arrhythmia detector and alarm. Elsewhere in
this issue of the Federal Register, FDA is publishing a final rule
reclassifying arrhythmia detector and alarm devices into class II with
a special controls guidance document. The final rule also establishes a
separate classification regulation for AEDs.
AEDs, primarily designed for an intended use (i.e., to correct an
arrhythmia) different from arrhythmia detector and alarm devices, have
a shock advisory algorithm, automatically detect a shockable cardiac
rhythm, and automatically deliver an electric shock (fully automated
device) or deliver a shock when activated by the operator
(semiautomated device). FDA regulates AEDs as class III devices. In
response to Advamed's petition (Ref. 1), FDA stated that it would
publish a notice of a panel meeting that would discuss the possible
reclassification of AEDs. In the December 13, 2002, proposed rule (67
FR 76706), FDA stated that it intended to propose the reclassification
of the AED at a later time.
FDA is publishing this document to provide interested persons with
an opportunity to submit any new information concerning the safety and
effectiveness of AEDs. After FDA reviews any information that it
receives in response to this notice, FDA will determine whether it
should go forward with the reclassification of AEDs and whether a panel
meeting is necessary before taking any action.
II. Reference
The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES). Interested persons may view this
reference between 9 a.m. and 4 p.m., Monday through Friday.
1. HIMA (Health Industry Manufacturers Association) (now known
as Advamed), reclassification petition, Docket No. 1994N-0418, vol.
1-7, Washington, DC, August 14, 1996.
Dated: October 2, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-27116 Filed 10-27-03; 8:45 am]
BILLING CODE 4160-01-S