Document ID: FDA-2011-N-0650-0005
Agency: fda
Document Type: Proposed Rule
Title: Cardiovascular Devices; Withdrawal of Proposed Rule of Reclassification of External Pacemaker Pulse Generator Devices
Posted Date: 2014-09-15T04:00Z

[Federal Register Volume 79, Number 178 (Monday, September 15, 2014)]
[Proposed Rules]
[Page 54927]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21816]

[[Page 54927]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2011-N-0650]

Cardiovascular Devices; Withdrawal of Proposed Rule of 
Reclassification of External Pacemaker Pulse Generator Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing the 
proposed rule the Agency issued in the Federal Register of October 17, 
2011. In that document, FDA proposed to reclassify the external 
pacemaker pulse generator (EPPG) devices, a preamendments class III 
device into class II (special controls). In response to the 
requirements under the Food and Drug Administration Safety and 
Innovation Act (FDASIA) and new information received during a panel 
meeting, FDA is withdrawing the proposed rule and issuing a proposed 
administrative order to reclassify EPPGs.

DATES: The proposed rule is withdrawn on September 15, 2014.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: 

I. Background--Regulatory Authorities

    On October 17, 2011, FDA published in the Federal Register (76 FR 
64223) a proposed rule proposing the reclassification of external 
pacemaker pulse generator (EPPG) devices from class III to class II 
with special controls. FDA identified special controls that the Agency 
believed would provide reasonable assurance of safety and effectiveness 
for the device type. FDA considered EPPGs in accordance with the 
reserved criteria and determined that the device type does require 
premarket notification.
    On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA (Pub. 
L. 112-144) amended section 513(e) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(e)) 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 on the classification of this 
device. 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 in class III (Ref. 1). There was Panel 
consensus that EPPG devices did not fit the regulatory definition of a 
class III device. Coupled with the rationale that special controls 
could be established to reasonably demonstrate an assurance of safety 
and effectiveness, the Panel recommended class II (special controls) 
for EPPG when intended for cardiac rate control or prophylactic 
arrhythmia prevention.

II. Withdrawal of the Proposed Rule

    FDA provided an opportunity for interested parties to comment on 
the proposed rule for EPPG (76 FR 64223). FDA received three comments 
to the docket in response to the 2011 proposed rule. These comments 
were received and have been considered during the presentations to the 
Panel and in developing the proposed order. In response to these 
comments and findings at the Panel meeting, FDA is withdrawing the 
proposed rule for these devices and is issuing a proposed 
administrative order.

III. Proposed Reclassification

    Elsewhere in this issue of the Federal Register, FDA is proposing 
in an order to reclassify EPPG devices, currently a preamendments class 
III device, into class II (special controls). FDA continues to review 
the merits of the submissions for requests for reclassification that 
meet the requirements under 21 CFR 860.123, submitted in response to 
the proposed rule.

IV. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and is available electronically at http://www.regulations.gov. (FDA has 
verified the Web site address in this reference section, but we are not 
responsible for any subsequent changes to the Web site after this 
document publishes in the Federal Register.)
    1. The panel 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/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/ucm342357.htm.

    Dated: September 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-21816 Filed 9-12-14; 8:45 am]
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