[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]
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