[Federal Register: October 28, 2003 (Volume 68, Number 208)]
[Page 61446]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 1994N-0418]

Medical Devices; Reclassification of Automated External 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of intent.


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.


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]