Cardiovascular Devices; Withdrawal of Proposed Rule of Reclassification of External Pacemaker Pulse Generator Devices, 54927 [2014-21816]
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Federal Register / Vol. 79, No. 178 / Monday, September 15, 2014 / Proposed Rules
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.
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.
SUMMARY:
The proposed rule is withdrawn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:
DATES:
rmajette on DSK2TPTVN1PROD with PROPOSALS
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,
VerDate Mar<15>2010
15:36 Sep 12, 2014
Jkt 232001
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 https://
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
PO 00000
Frm 00011
Fmt 4702
Sfmt 4702
54927
https://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]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 870
[Docket No. FDA–2011–N–0650]
Cardiovascular Devices;
Reclassification of External Pacemaker
Pulse Generator Devices;
Reclassification of Pacing System
Analyzers
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Proposed order.
The Food and Drug
Administration (FDA) is proposing in
this administrative order to reclassify
the external pacemaker pulse generator
(EPPG) devices, a preamendments class
III device into class II (special controls),
and to amend the device identification
and reclassify the pacing system
analyzers (PSAs) into class II (special
controls). Specifically, single and dual
chamber PSAs, which are currently
classified with EPPG devices, and triple
chamber PSAs (TCPSAs), which are
postamendments class III devices, are
proposed to be reclassified to class II
devices. FDA is proposing this
reclassification based on new
information pertaining to the device.
This proposed action would implement
certain statutory requirements.
DATES: Submit either electronic or
written comments on the proposed
order by December 15, 2014. See section
XII for the effective date of any final
order that may publish based on this
proposed order.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2011–N–
0650, by any of the following methods:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
E:\FR\FM\15SEP1.SGM
15SEP1
]]>Agencies
[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.
-----------------------------------------------------------------------
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 https://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 https://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]
BILLING CODE 4164-01-P
