[Federal Register Volume 62, Number 107 (Wednesday, June 4, 1997)]
[Rules and Regulations]
[Pages 30456-30457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14597]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. 93N-0027]


Neurological Devices; Effective Date of Requirement for Premarket 
Approval of Cranial Electrotherapy Stimulators

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule 
to revoke a regulation requiring that a premarket approval application 
(PMA) or a notice of completion of a product development protocol (PDP) 
be submitted for the cranial electrotherapy stimulator (CES), a medical 
device. This action is being taken in order that FDA may reconsider 
whether the CES device may be reclassified from class III (premarket 
approval) into class II (special controls) or class I (general 
controls). Elsewhere in this issue of the Federal Register, FDA is 
issuing an order requiring manufacturers of these devices to submit 
information concerning their safety and effectiveness.

EFFECTIVE DATE: July 7, 1997.

FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices 
and Radiological Health (HFZ-215), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-827-2974.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of September 4, 1979 (44 FR 51770), FDA 
published a final rule classifying the CES device into class III 
(premarket approval). This regulation was codified in Sec. 882.5800 (21 
CFR 882.5800). Section 882.5800 applies to: (1) Any CES that was in 
commercial distribution before May 28, 1976, the date of enactment of 
the Medical Device Amendments of 1976 (the amendments) (Pub. L. 94-
295); and (2) any device that FDA has found to be substantially 
equivalent to the CES and that has been marketed on or after May 28, 
1976.
    In the Federal Register of August 31, 1993 (58 FR 45865), FDA 
published a proposed rule to require the filing of a PMA or a notice of 
completion of a PDP for the CES, under section 515(b) of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(b)). In 
accordance with section 515(b)(2)(A) of the act, FDA included in the 
preamble to the proposal the agency's proposed findings with respect to 
the degree of risk of illness or injury designed to be eliminated or 
reduced by requiring the device to meet the premarket approval 
requirements of the act and the benefits to the public from the use of 
the device (58 FR 45865 at 45867). The primary concern expressed in the 
preamble to the proposed rule was the varying and contradictory results 
in investigations concerning the effectiveness of the CES device. FDA's 
conclusion at that time was that: ``FDA believes that CES's should 
undergo premarket approval to establish effectiveness for any intended 
use and to determine whether the benefits to the patient are sufficient 
to outweigh any risk'' (58 FR 45865 at 45868).
    The August 31, 1993, proposed rule also provided an opportunity for 
interested persons to submit comments on the proposed rule and the 
agency's proposed findings. Under section 515(b)(2)(B) of the act, FDA 
also provided an opportunity for interested persons to request a change 
in the classification of the device based on new information relevant 
to its classification. Any petition requesting a change in the 
classification of the CES was required to be submitted by September 15, 
1993. The comment period closed on November 1, 1993.
    FDA received two petitions requesting a change in the 
classification of the device from class III to class II. FDA reviewed 
the petitions and found them to be deficient based on a lack of new 
information relevant to the device's classification. Each petitioner 
was sent a deficiency letter dated February 4, 1994, requesting a 
response to the reported deficiencies. Neither petitioner responded to 
the letter. Accordingly, the petitioners were notified on August 23, 
1994, that the petitions were deemed closed.
    In the Federal Register of August 24, 1995 (60 FR 43967), FDA 
issued a final rule to require the submission of a PMA or notice of 
completion of a PDP for the CES device. In that document, FDA also 
published a final order denying the petitions to reclassify the device. 
One PMA was submitted and filed for the

[[Page 30457]]

device. FDA has since become aware of additional information relevant 
to the possible reclassification of the CES device from class III to 
class II or class I. In the Federal Register of January 28, 1997 (62 FR 
4023), FDA published a proposed rule to revoke the requirement that a 
PMA or a notice of completion of a PDP be filed for the CES device. FDA 
explained that it now believes that it is more appropriate to invoke 
the procedures under section 515(i) of the act for the device.
    FDA provided an opportunity for interested persons to comment on 
the proposed rule. FDA received 41 comments. All but two of these 
comments directly supported the proposal to revoke the requirement that 
a PMA or notice of completion of a PDP be filed for the CES device. 
Many of the comments also requested that the CES device be reclassified 
into class I or II. Some comments submitted information in support of 
reclassification of the device. One comment included a paper addressing 
the government's role in regulating ``alternative medicine'' including, 
according to the comment, CES. Another comment submitted anecdotal 
information about a negative experience with CES but did not 
specifically take a position with respect to revocation of the 
requirement to submit a PMA. One comment supported the revocation of 
the requirement to submit a PMA, but suggested that FDA should, in all 
cases, issue an order under section 515(i) before it issues a proposed 
rule to require the submission of a PMA.
    As noted above, elsewhere in this issue of the Federal Register, 
FDA is issuing an order under section 515(i) of the act to require 
manufacturers of CES devices to submit information to FDA about the 
safety and effectiveness of the devices. FDA will review all 
information submitted in response to that order and in the comments 
submitted on the proposed revocation to determine whether to reclassify 
the device.
    In response to the suggestion that FDA not issue a rule under 
section 515(b) of the act without first issuing an order under section 
515(i) of the act, as FDA previously stated in the Federal Register of 
May 6, 1994 (59 FR 23731), the Safe Medical Devices Act (SMDA) (Pub. L. 
101-629) does not prevent FDA from proceeding immediately to rulemaking 
under section 515(b) of the act on specific devices, in the interest of 
the public health, independent of the procedure in section 515(i) of 
the act. FDA will consider the suggestion on a case-by-case basis.

II. Environmental Impact

    The agency has determined under 21 CFR 25.24(a)(8) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

III. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this final rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the final 
rule is not a significant regulatory action as defined by the Executive 
Order and so is not subject to review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because this final rule will allow FDA to review 
information about these devices and determine the least burdensome 
degree of control needed to provide reasonable assurance of the safety 
and effectiveness of the CES device, the Commissioner of Food and Drugs 
certifies that the final rule will not have a significant economic 
impact on a substantial number of small entities. Therefore, under the 
Regulatory Flexibility Act, no further analysis is required.

List of Subjects in 21 CFR Part 882

    Medical devices.
    Therefore under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
882 is amended as follows:

PART 882--NEUROLOGICAL DEVICES

    1. The authority citation for 21 CFR part 882 continues to read as 
follows:

    Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 
371).
    2. Section 882.5800 is amended by revising paragraph (c) to read as 
follows:

Sec. 882.5800  Cranial electrotherapy stimulator.

* * * * *
    (c) Date a PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 882.3.

    Dated: May 28, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-14597 Filed 6-3-97; 8:45 am]
BILLING CODE 4160-01-F