[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DATES: The proposed rule and the proposed order, in part, are withdrawn 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, 
[email protected].

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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