[Federal Register Volume 62, Number 18 (Tuesday, January 28, 1997)]
[Proposed Rules]
[Pages 4023-4024]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-1929]


 ========================================================================
 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 62, No. 18 / Tuesday, January 28, 1997 / 
Proposed Rules  

[[Page 4023]]



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: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a proposed 
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).

DATES: Written comments by February 12, 1997. FDA intends that any 
final rule that may issue based on this proposal become effective on 
the date of its publication in the Federal Register.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

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 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 (21 U.S.C. 
360c(b)(2)(A)), 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' 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 Federal Register 
document, FDA also published a final order denying the petitions to 
reclassify the device. One PMA was submitted and filed for the 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. Accordingly, FDA is proposing to revoke the August 24, 
1995, final rule. Revocation of the final rule is necessary if FDA is 
to pursue possible reclassification of the device without a break in 
commercial distribution. This is because, under the August 24, 1995, 
final rule, devices which are not subject to an approved PMA on or 
before January 28, 1997, are deemed adulterated.
    FDA believes that it is more appropriate to invoke the procedures 
under section 515(i) of the act for this device. Under that section, 
FDA would issue an order requiring manufacturers of CES devices to 
submit to FDA information concerning the safety and effectiveness of 
the device. FDA would then review the information submitted in response 
to this order and any other information available to FDA and determine 
whether to reclassify the device into class II or class I. If FDA were 
to decide not to reclassify the device, it would publish a new proposed 
rule under section 515(b) of the act to require the submission of 
PMA's.

II. Comments

    Comments on the proposed revocation must be submitted by February 
12, 1997. In accordance with 10.40(b)(2) (21 CFR 10.40(b)(2)). FDA has 
decided that there is good cause to shorten the usual comment period 
for the proposed revocation of the August 24, 1995, final rule for 
several reasons.
    First, a longer comment period on the revocation is impracticable. 
In accordance with section 515(d)(1)(B)(i) of the act, the agency's 
decision to either approve or deny premarket approval

[[Page 4024]]

applications for this device must be issued no later than January 28, 
1997. As long as the August 24, 1995, final rule remains in effect, 
devices not subject to approved premarket approval applications on that 
date would be adulterated under section 501(f)(1) of the act (21 U.S.C. 
351(f)(1)). It is not possible for the agency to propose revocation of 
the August 24, 1995, final rule, offer a lengthy opportunity for 
comment on the proposed revocation, and issue a final revocation by 
January 28, 1997. Therefore, the agency has concluded that it is 
impracticable to offer a comment period of longer than 15 days on the 
proposed revocation of the August 24, 1995, final rule. Even with a 
shortened comment period, the agency will not be able to issue a final 
revocation prior to that date. Accordingly, the agency intends to 
exercise its enforcement discretion not to take regulatory action 
against the device during the short time it expects it will take to 
complete this rulemaking.
    Second, a longer comment period would be contrary to the public 
interest. For the reasons discussed above, the agency has concluded 
that it is more appropriate to invoke the procedures in section 515(i) 
of the act for this device. It is possible that, as a result of those 
procedures, the device may be reclassified and not subject to premarket 
approval at all. A lengthy comment period would prevent the revocation 
from becoming effective in time to ensure continuity of regulation. 
Moreover, removal of the device from the market prior to full 
consideration of the information that would be obtained under section 
515(i) of the act would cause great disruption to both users and 
manufacturers of the device and would have financial consequences. 
Therefore, the agency has concluded that it is in the public interest 
to shorten the comment period on this proposed revocation to 15 days.
    Finally, the issues presented by the proposed revocation are, 
essentially, the same issues presented by the proposed rule to require 
premarket approval applications for this device. The agency received no 
comments expressing urgency that the device be subjected to premarket 
approval requirements. Further, the original classification panel 
recommended that the CES be considered a low priority for requiring 
premarket approval (43 FR 55640: November 28, 1978). FDA believes, 
therefore, that the shorter comment period will not deprive interested 
persons of the opportunity to express their views on the proposed 
revocation.
    For the reasons discussed above, a comment period of longer than 15 
days would be impracticable and contrary to the public interest. 
Therefore, FDA concludes that there is good cause for shortening the 
comment period on the proposed revocation of the August 24, 1995, final 
rule to 15 days.

III. 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.

IV. Analysis of Impacts

    FDA has examined the impacts of the proposed 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 proposed rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the proposed 
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 proposed rule, if finalized, 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 agency certifies 
that the proposed 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.

 V. Request for Comments

    Interested persons may, on or before February 12, 1997 submit to 
the Dockets Management Branch (address above) written comments 
regarding this proposal. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.

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, it is 
proposed that 21 CFR part 882 be amended as follows:

PART 882--NEUROLOGICAL DEVICES

    1. The authority citation for 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 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: January 22, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-1929 Filed 1-27-97; 8:45 am]
BILLING CODE 4160-01-F