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

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]

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