Document ID: FDA-2011-D-0649-0003
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: External Pacemaker Pulse Generator; Withdrawal of Draft Guidance
Posted Date: 2014-09-15T04:00Z

[Federal Register Volume 79, Number 178 (Monday, September 15, 2014)]
[Notices]
[Pages 54986-54987]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21815]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0649]

Draft Guidance for Industry and Food and Drug Administration 
Staff; Class II Special Controls Guidance Document: External Pacemaker 
Pulse Generator; Withdrawal of Draft Guidance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
withdrawal of the draft guidance entitled ``Class II Special Controls 
Guidance Document: External Pacemaker Pulse Generator,'' dated October 
2011, in response to the requirements of the Food and Drug 
Administration Safety and Innovation Act (FDASIA) and new input 
received during a panel meeting.

DATES: The withdrawal is effective September 15, 2014.

FOR FURTHER INFORMATION CONTACT: Hina Pinto, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave. Bldg. 66, Rm. 1652, Silver Spring, MD 20993, 301-796-6351.

SUPPLEMENTARY INFORMATION:
    In a notice published in the Federal Register of October 17, 2011 
(76 FR 64228), FDA announced the availability of a draft special 
controls guidance document that, if finalized, would serve as a special 
control if FDA reclassified these devices. FDA believed that the 
special controls described in the draft guidance entitled, ``Class II 
Special Controls Guidance Document: External Pacemaker Pulse 
Generator'' would be sufficient to mitigate the risks to health 
associated with the external pacemaker pulse generator (EPPG) (Ref. 1).
    On July 9, 2012, FDASIA (Pub. L. 112-144) was enacted. Section 
608(a) of FDASIA amended section 513(e) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(a)) changing the process 
for reclassifying a device from rulemaking to an administrative order. 
Subsequent to the publication of the proposed rule, FDASIA's amendments 
to section 513 of the FD&C Act required FDA to hold a classification 
panel (an FDA advisory committee) meeting to discuss the classification 
of this device type. On September 11, 2013, a meeting of the 
Circulatory System Devices Panel (the Panel) was held to discuss 
whether EPPG devices should be reclassified or remain as class III 
devices (Ref. 2). The Panel recommended that EPPG devices be 
reclassified to class II with special controls when intended for 
cardiac rate control or prophylactic arrhythmia prevention.
    FDA provided an opportunity for interested parties to comment on 
the special control guidance on EPPG. FDA did not receive any comments 
to the docket. As a result of the Panel recommendation and the 
amendment to section 513(e) of the FD&C Act, FDA will now include the 
special controls for EPPG devices in a proposed order published 
elsewhere in this issue of the Federal Register and withdraw the draft 
guidance through this notice.

References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES), and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov. (FDA 
has verified the Web site addresses, but we are not responsible for any 
subsequent changes to the Web sites after this document publishes in 
the Federal Register.)
    1. Class II Special Controls Draft Guidance Document: External 
Pacemaker Pulse Generator, available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM275703.pdf.
    2. The transcript and other meeting materials for the September 11, 
2013, Circulatory System Devices Panel are available on FDA's Web site 
at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/
MedicalDevices/

[[Page 54987]]

MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/
ucm342357.htm.

    Dated: September 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-21815 Filed 9-12-14; 8:45 am]
BILLING CODE 4164-01-P