[Federal Register Volume 79, Number 113 (Thursday, June 12, 2014)]
[Proposed Rules]
[Page 33712]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-13756]
[[Page 33712]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 882
[Docket Nos. FDA-2011-N-0504 and FDA-2013-N-0195]
Neurological Devices; Withdrawal of Proposed Effective Date of
Requirement for Premarket Approval for Cranial Electrotherapy
Stimulator Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Withdrawal of proposed rule and proposed order.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing the
proposed rule the Agency issued in the Federal Register of August 8,
2011, and the proposed order the Agency issued in the Federal Register
of April 4, 2013, in part. In those documents, FDA proposed to require
the filing of a premarket approval application (PMA) or a notice of
completion of a product development protocol (PDP) for the class III
preamendment device, cranial electrotherapy stimulator (CES). In
response to information received in response to these two proposed
actions, FDA is withdrawing the proposed rule and proposed order.
DATES: The proposed rule and the proposed order, in part, are withdrawn
on June 12, 2014.
FOR FURTHER INFORMATION CONTACT: Melissa Burns, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1646, Silver Spring, MD 20993, 301-796-5616,
Melissa.Burns@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background--Regulatory Authorities
In the Federal Register of August 8, 2011 (76 FR 48062), FDA issued
a proposed rule to require the filing of a PMA or a notice of
completion of a PDP for the class III preamendments device, CES. This
device applies electrical current to a patient's head to treat
insomnia, depression, or anxiety. The Agency also summarized its
proposed findings regarding the degree of risk of illness or injury
designed to be eliminated or reduced by requiring the devices to meet
the statute's approval requirements and the benefits to the public from
the use of the devices. In addition, FDA announced the opportunity for
interested persons to request that the Agency change the classification
of any of the aforementioned devices based on new information.
In response to the proposed rule, FDA received three petitions
conforming to the requirements of 21 CFR 860.123 requesting a change in
the classification of CES devices. FDA referred the petitions to the
Neurological Device Panel (``the Panel'') on February 10, 2011, for the
Panel's recommendation on the requested change in classification (Ref.
1). The Panel recommended that the CES device for treatment of
insomnia, depression, or anxiety should remain in class III requiring
PMAs.
On July 9, 2012, the Food and Drug Administration Safety and
Innovation Act (FDASIA) was enacted. Section 608(a) of FDASIA (126
Stat. 1056) 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.
Subsequently, on April 4, 2013 (78 FR 20268), FDA issued a proposed
administrative order for several device types, including CES, to comply
with the new procedural requirement created by FDASIA. This proposed
order also proposed requiring filing of a PMA or a notice of completion
of a PDP for the CES device.
II. Withdrawal of the Proposed Rule and Proposed Order
FDA provided an opportunity for interested parties to comment on
the proposed rule and proposed order for CES devices (76 FR 48062,
August 8, 2011, and 78 FR 20268, April 4, 2013). FDA received over 300
comments to the docket in response to the proposed rule and proposed
order related to CES devices. Comments that expressed an opinion about
the classification of CES devices were usually in favor of a class II
designation. Some comments did not openly state an opinion, but
included arguments against the proposed rule or order that could
reasonably be interpreted as support for a class II designation. There
were also comments that agreed with a class III designation. In
addition to the comments, FDA received four separate submissions to
request a change in the classification of CES from class III to class
II. FDA has considered the information before the Agency, including the
deliberations of the February 10, 2012, Neurological Devices Panel and
the reclassification petitions submitted for these devices, and has
determined that there is sufficient information to establish special
controls, and that these special controls, together with general
controls, will provide a reasonable assurance of safety and
effectiveness for CES devices. In this action, FDA is withdrawing the
proposed rule and proposed order to call for PMAs for CES devices. FDA
plans to issue a proposed order in the future for the reclassification
of the CES device into class II. For the reasons described in this
document, FDA is withdrawing the aforementioned proposed rule and
proposed order.
III. 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. FDA's Neurological Devices Panel transcript and other meeting
materials are available on FDA's Web site at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/ucm289361.htm.
Dated: June 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13756 Filed 6-11-14; 8:45 am]
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