[Federal Register Volume 62, Number 107 (Wednesday, June 4, 1997)]
[Notices]
[Pages 30600-30603]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14599]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0190]
Cranial Electrotherapy Stimulators; Submission of Safety and
Effectiveness Information
AGENCY: Food and Drug Administration, HHS.
[[Page 30601]]
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is issuing an order
requiring manufacturers of cranial electrotherapy stimulators (CES) to
submit to FDA a summary of, and citation to, all information known or
otherwise available to them respecting the device, including adverse
safety and effectiveness information concerning the device that has not
been submitted under the Federal Food, Drug, and Cosmetic Act (the
act). FDA is requesting this information in order to determine whether
the classification of the device should be revised, or whether a
regulation requiring the submission of a premarket approval application
(PMA) for the device should be issued. Elsewhere in this issue of the
Federal Register, FDA is issuing a final rule to revoke the requirement
that manufacturers of CES devices submit a PMA or notice of completion
of a product development protocol (PDP) for the device.
DATES: Summaries and citations must be submitted by August 14, 1998.
ADDRESSES: Submit summaries and citations to the Documents Mail Center
(HFZ-401), Center for Devices and Radiological Health, Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850.
FOR FURTHER INFORMATION CONTACT: Doreen M. Melling, Center for Devices
and Radiological Health, Food and Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 301-594-2186.
SUPPLEMENTARY INFORMATION:
I. Background
Section 513 of the act (21 U.S.C. 360c) requires the classification
of medical devices into one of three regulatory classes: Class I
(general controls), class II (special controls), and class III
(premarket approval). Generally, devices that were on the market before
May 28, 1976, the date of enactment of the Medical Device Amendments of
1976 (the amendments) (Pub. L. 94-295), and devices marketed on or
after that date that are substantially equivalent to such devices, have
been classified by FDA. This notice refers to both the devices that
were on the market before May 28, 1976, and the substantially
equivalent devices that were marketed on or after that date, as
``preamendments devices.''
Section 515(b)(1) of the act (21 U.S.C. 360e(b)(1)) establishes the
requirement that a preamendments device that FDA has classified into
class III is subject to premarket approval. However, submission of a
PMA, or a notice of completion of a PDP is not required until 90 days
after FDA issues a final rule requiring premarket approval for the
device, or 30 months after final classification of the device,
whichever is later. Also, such a device is exempt from the
investigational device exemption (IDE) regulations of 21 CFR part 812
until the date stipulated by FDA in the final rule requiring the
submission of a PMA for that device. If a PMA or a notice of completion
of a PDP is not filed by the later of the two dates, commercial
distribution of the device is required to cease. The device may,
however, be distributed for investigational use if the manufacturer,
importer, or other sponsor of the device complies with the IDE
regulations.
The Safe Medical Devices Act of 1990 (the SMDA) (Pub. L. 101-629)
changed the definition of class II devices from those for which a
performance standard is necessary to provide reasonable assurance of
safety and effectiveness to those for which there is sufficient
information to establish special controls to provide such assurance.
Special controls include performance standards, postmarket
surveillance, patient registries, guidelines (including guidelines for
the submission of clinical data in premarket notification submissions
in accordance with section 510(k)), recommendations, and other
appropriate actions the agency deems necessary to provide such
assurance. Thus, the SMDA modified the definition of class II devices
to permit reliance on special controls, rather than performance
standards alone, to provide reasonable assurance of safety and
effectiveness.
The SMDA also added new section 515(i) of the act. This section
requires FDA to order manufacturers of preamendments class III devices
for which no final regulation has been issued requiring the submission
of PMA's to submit to the agency a summary of, and a citation to, any
information known or otherwise available to them respecting such
devices, including adverse safety and effectiveness information which
has not been submitted under section 519 of the act (21 U.S.C. 360i).
Section 519 of the act requires manufacturers, importers, or
distributors to maintain records and to report information that
reasonably suggests that one of its marketed devices may have caused or
contributed to a death or serious injury, or that a malfunction of the
device is likely to cause death or serious injury on recurrence.
Section 515 (i) of the act also directs FDA to either revise the
classification of the device into class I or class II or require the
device to remain in class III; and, for devices remaining in class III,
to establish a schedule for the issuance of a rule requiring the
submission of PMA's for the device.
In the Federal Register of August 24, 1995 (60 FR 43967), FDA
issued a final rule to require the submission of a PMA or a notice of
completion of a PDP for the CES device. FDA had not issued an order
under section 515(i) of the act for the CES device before issuing this
final rule. FDA has since become aware of additional information
relevant to the possible reclassification of the device from class III
to class II or class I. As a result, in the Federal Register of January
28, 1997 (62 FR 4023), FDA proposed to revoke the rule requiring the
submission of a PMA or notice of completion of a PDP. At that time, FDA
said that it believed that it is more appropriate to invoke the
procedures under section 515(i) of the act for the CES device.
Elsewhere in this issue of the Federal Register, FDA is issuing a final
rule based on the proposal (62 FR 4023).
In this document, FDA is requiring manufacturers of CES devices to
submit a summary of, and citation to, all safety and effectiveness
information known or otherwise available to them respecting such
devices, including adverse information concerning the devices which has
not been submitted under section 519 of the act.
II. Statutory Authority and Enforcement
In addition to the provisions of section 515(i) of the act
described in section I of this document, this order is issued under
section 519 of the act, as implemented by Sec. 860.7(g)(2) (21 CFR
860.7(g)(2)). This regulation authorizes FDA to require reports or
other information bearing on the classification of a device. Section
519 of the act also requires the reporting of any death or serious
injury caused by a device or by its malfunction.
Failure to furnish the information required by this order results
in the device being misbranded under section 502(t) of the act (21
U.S.C. 352(t)) and is a prohibited act under sections 301(a) and (q) of
the act (21 U.S.C. 331(a) and (q)). The agency will use its enforcement
powers to deter noncompliance. Violations of section 301 of the act may
be subject to seizure or injunction under sections 304(a) and 302(a) of
the act (21 U.S.C. 334(a) and 332(a) respectively). In addition,
violations under section 301 of the act may be subject to civil
penalties under section 303(f) of the act (21 U.S.C. 333(f)), and
criminal prosecution under section 303(a) of the act.
[[Page 30602]]
III. Order
The agency is hereby issuing this order under sections 515(i) and
519 of the act and Sec. 860.7(g)(1) of the regulations. Under the
order, the required information shall be submitted by August 14, 1998,
so that FDA may begin promptly the process established by section
515(i) of the act to either revise or sustain the current
classification of these devices.
IV. Required Contents of Submissions
By the date listed in section III of this document, all
manufacturers currently marketing CES devices shall provide a summary
of, and citation to, any information known or otherwise available to
them respecting the devices, including adverse safety and effectiveness
data which has not been submitted under section 519 of the act. FDA
suggests that it may be in the best interest of submitters to summarize
the information submitted under section 519 of the act to facilitate
FDA's decision making, even though such information is not required.
The information should be submitted in one of the two following
formats depending on whether the applicant is aware of any information
which would support the reclassification of the device into class I
(general controls) or class II (special controls). Information which
would support the reclassification of the device must consist of
adequate, valid scientific evidence showing that general controls alone
(class I), or general controls and special controls (class II) will
provide a reasonable assurance of the safety and effectiveness of the
device.
For manufacturers who do not believe that existing information
would support the reclassification of their device into class I or
class II, the information provided should be submitted in the following
format:
1. Indications for use. A general description of the disease or
condition to be diagnosed, treated, cured, mitigated, or prevented,
including a description of the patient population for which the device
is intended.
2. Device description. An explanation of how the device functions,
significant physical and performance characteristics of the device, and
basic scientific concepts that form the basis for the device.
3. Other device labeling. Other device labeling that includes
contraindications, warnings and precautions and/or promotional
materials.
4. Risks. A summary of all adverse safety and effectiveness
information and identification of the risks presented by the device as
well as any mechanisms or procedures which will control the risk.
5. Alternative practices and procedures. A description of
alternative practices or procedures for diagnosing, treating,
preventing, curing, or mitigating the disease or condition for which
the device is intended.
6. Summary of preclinical and clinical data. The summary of
preclinical and clinical data should include the conclusions drawn from
the studies which support the safety and effectiveness of the device as
well as special controls, if any, which address the adverse effects of
the device on health. The summary should include a brief description of
the objective of the studies, the experimental design, how the data
were collected and analyzed, and a brief description of the results of
the studies, whether positive, negative, or inconclusive. The summary
of the clinical study(ies) should also include a discussion of the
subject inclusion and exclusion criteria, the study population, reasons
for patient discontinuations, and results of statistical analyses.
7. Bibliography. A copy of the key references, a brief summary of
the salient features of each key reference, and a brief discussion of
why the reference is relevant to an evaluation of the safety and
effectiveness evaluation of the device.
Manufacturers who believe that existing information would support
the reclassification of their device into class I or class II may
either submit information using the format described below or may
submit a formal reclassification petition which should include the
information described below in addition to the information required
under 21 CFR 860.123.
1. Identification. A brief narrative identification of the device.
Where appropriate, this identification should include a listing of the
materials, and the component parts, and a description of the intended
use of the device.
2. Risks to health. An identification of the risks to health should
summarize all adverse safety and effectiveness information, which have
not been submitted under section 519 of the act particularly the most
significant. The mechanisms or procedures which will control the risk
should be described. A list of the general hazards associated with the
device and a bibliography with copies of the referenced material should
be provided.
3. Recommendation. A statement whether the manufacturer believes
the device should be reclassified into class I or class II.
4. Summary of reasons for recommendation. Each manufacturer should
include a summary of the reasons for requesting reclassification of its
device and an explanation why it believes the device meets the
statutory criteria for reclassification into class I or class II. Each
manufacturer should also identify the special controls that it believes
would be sufficient to provide reasonable assurance of the safety and
effectiveness of its device if it believes the device should be
reclassified into class II.
5. Summary of valid scientific evidence on which the recommendation
is based. Manufacturers are advised that, when considering a formal
reclassification petition, FDA will rely only upon valid scientific
evidence to determine that there is a reasonable assurance of the
safety and effectiveness of the device, if regulated by general
controls alone (class I) or by general controls and special controls
(class II). Valid scientific evidence consists of evidence from well-
controlled investigations, particularly controlled studies, studies and
objective trials without matched controls, well documented case
histories conducted by qualified experts, and reports of significant
human experience with a marketed device, from which it can fairly and
responsibly be concluded by qualified experts that there is reasonable
assurance of the safety and effectiveness of a device under its
conditions of use. The evidence required may vary according to the
characteristics of the device, its conditions of use, the existence and
adequacy of warnings and other restrictions, and the extent of
experience with its use. Isolated case reports, random experience,
reports lacking sufficient details to permit scientific evaluation, and
unsubstantiated opinions are not regarded as valid scientific evidence
to show safety or effectiveness. (See Sec. 860.7(c)(2)).
According to Sec. 860.7(d)(1), there is reasonable assurance that a
device is safe when it can be determined, based upon valid scientific
evidence, that the probable benefits to health from use of the device
for its intended uses and conditions of use, when accompanied by
adequate directions and warnings against unsafe use, outweigh any
probable risks. The valid scientific evidence used to determine the
safety of a device shall adequately demonstrate the absence of
unreasonable risk of illness or injury associated with the use of the
device for its intended uses and conditions for use. Moreover, in
accordance to Sec. 860.7(e)(1), there is reasonable assurance that a
device is
[[Page 30603]]
effective when it can be determined, based upon valid scientific
evidence, that in a significant portion of the target population, the
use of the device for its intended uses and conditions of use, when
accompanied by adequate directions for use and warnings against unsafe
use, will provide clinically significant results.
Manufacturers submitting a formal reclassification petition may
wish to request two petitions as examples of successful
reclassification petitions.
Magnetic resonance imaging devices, Docket Nos. 87P-0214/CP1
through CP13, and Nd:YAG Laser for posterior capsulotomy devices,
Docket No. 86P-0083, were both reclassified from class III to class II
following the submission of reclassification petitions. Both petitions
are available upon submission of a Freedom of Information request to
the Freedom of Information Staff (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 12A-30, Rockville, MD 20857.
V. Submission of Required Information
The summary of and citation to, any information required by the act
must be submitted by August 14, 1998, to the Document Mail Center
(address above).
Dated: May 28, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 97-14599 Filed 6-3-97; 8:45 am]
BILLING CODE 4160-01-F
