Federal Register, Volume 63 Issue 13 (Wednesday, January 21, 1998)

[Federal Register Volume 63, Number 13 (Wednesday, January 21, 1998)]
[Notices]
[Pages 3142-3145]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-1485]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0015]

Medical Devices; Exemptions From Premarket Notification; Class II
Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
class II (special controls) devices, subject to certain limitations,
that are now exempt from the premarket notification requirements under
the Food and Drug Administration Modernization Act of 1997 (the FDAMA).
FDA believes that these exemptions will relieve manufacturers from the
need to submit premarket notification submissions for these devices and
will enable FDA to redirect the resources that would be spent on
reviewing such submissions to more significant public health issues.
FDA is taking this action in order to meet a requirement of the FDAMA.

DATES: Effective January 21, 1998. Comments on this notice should be
submitted within 90 days of publication. The agency will review any
comments submitted within the 90-day comment period and will consider
whether the list of class II devices that are exempt from the premarket
notification requirements should be modified.

ADDRESSES: Submit written comments on this notice to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Heather S. Rosecrans, Center for
Devices and Radiological Health (HFZ-404), Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
1190.

SUPPLEMENTARY INFORMATION:

I. Statutory Background

Under section 513 of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 360c), FDA must classify devices into one of three
regulatory classes: Class I, class II, or class III. FDA classification
of a device is determined by the amount of regulation necessary to
provide a reasonable assurance of safety and effectiveness. Under the
Medical Device Amendments of 1976 (the 1976 amendments (Pub. L. 94-
295)), as amended by the the Safe Medical Devices Act of 1990 (the SMDA
(Pub. L. 101-629)), devices are to be classified into class I (general
controls) if there is information showing that the general controls of
the act are sufficient to assure safety and effectiveness; into class
II (special controls), if general controls, by themselves, are
insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls to provide such assurance; and into class III (premarket
approval), if there is insufficient information to support classifying
a device into class I or class II and the device is a life-sustaining
or life-supporting device or is for a use which is of substantial
importance in preventing impairment of human health, or presents a
potential unreasonable risk of illness or injury.
Most generic types of devices that were on the market before the
date of the 1976 amendments (May 28, 1976) (generally referred to as
preamendments devices) have been classified by FDA under the procedures
set forth in section 513(c) and (d) of the act through the issuance of
classification regulations into one of these three regulatory classes.
Devices introduced into interstate commerce for the first time on or
after May 28, 1976 (generally referred to as postamendments devices)
are classified through the premarket notification process under section
510(k) of the act (21 U.S.C. 360(k)). Section 510(k) of the act and the
implementing regulations, 21 CFR part 807, require persons who intend
to market a new device to submit a premarket notification report
containing information that allows FDA to determine whether the new
device is ``substantially equivalent'' within the meaning of section
513(I) of the act to a legally marketed device that does not require
premarket approval. Unless exempted from premarket notification
requirements, persons may not market a new device, under section
510(k), unless they receive a substantial equivalence order from FDA or
an order reclassifying the device into class I or class II (section
513(I) of the act).
On November 21, 1997, the President signed into law the FDAMA.
Section

[[Page 3143]]

206 of the FDAMA, in part, added a new section 510(m) to the act.
Section 510(m)(1) of the act requires FDA, within 60 days after
enactment of the FDAMA, to publish in the Federal Register a list of
each type of class II device that does not require a report under
section 510(k) of the act (generally referred to as a premarket
notification or ``510(k)'') to provide reasonable assurance of safety
and effectiveness. Section 510(m) of the act further provides that a
510(k) will no longer be required for these devices upon the date of
publication of the list in the Federal Register.
Section 510(m)(2) of the act provides that, 1 day after date of
publication of the list under section 510(m)(1), FDA may exempt a
device on its own initiative or upon petition of an interested person,
if FDA determines that a 510(k) is not necessary to provide reasonable
assurance of the safety and effectiveness of the device. This section
requires FDA to publish in the Federal Register a notice of intent to
exempt a device, or of the petition, and to provide a 30-day comment
period. Within 120 days of publication of this document, FDA must
publish in the Federal Register its final determination. If FDA fails
to respond to a petition under this section within 180 days of
receiving it, the petition shall be deemed granted.

II. Criteria for Exemption

In considering whether to exempt class II devices from premarket
notification, FDA focused on whether premarket notification for the
type of device is necessary to provide reasonable assurance of safety
and effectiveness of the device. FDA considered the following factors:
(1) The device does not have a significant history of false or
misleading claims or of risks associated with inherent characteristics
of the device, such as device design or materials (when making these
determinations, FDA has considered the risks associated with false or
misleading claims, and the frequency, persistence, cause or seriousness
of the inherent risks of the device); (2) characteristics of the device
necessary for its safe and effective performance are well established;
(3) changes in the device that could affect safety and effectiveness
will either: (a) Be readily detectable by users by visual examination
or other means such as routine testing, before causing harm, e.g.,
testing of a clinical laboratory reagent with positive and negative
controls; or (b) not materially increase the risk of injury, incorrect
diagnosis, or ineffective treatment; and (4) any changes to the device
would not be likely to result in a change in the device's
classification.
FDA also considered that even when exempting devices, these devices
would still be subject to the limitations on exemptions, as described
in section III of this document.

III. Limitations on Exemptions

The exemption from the requirement of premarket notification for a
generic type of device listed in this document applies only to those
devices that have existing or reasonably foreseeable characteristics of
commercially distributed devices within that generic type, or, in the
case of in vitro diagnostic devices, for which a misdiagnosis, as a
result of using the device, would not be associated with high morbidity
or mortality. Accordingly, a class II device listed in this document is
not exempt if such device: (1) Has an intended use that is different
from the intended use of a legally marketed device in that generic
type; e.g., the device is intended for a different medical purpose, or
the device is intended for lay use instead of use by health care
professionals; or (2) operates using a different fundamental scientific
technology than that used by a legally marketed device in that generic
type; e.g., a surgical instrument cuts tissue with a laser beam rather
than with a sharpened metal blade, or an in vitro diagnostic device
detects or identifies infectious agents by using a deoxyribonucleic
acid (DNA) probe or nucleic acid hybridization or amplification
technology rather than culture or immunoassay technology; or (3) is an
in-vitro device: That is intended for use in the diagnosis, monitoring
or screening of neoplastic diseases with the exception of
immunohistochemical devices; is intended for use in screening or
diagnosis of familial and acquired genetic disorders, including inborn
errors of metabolism; is intended for measuring an analyte which serves
as a surrogate marker for screening, diagnosis, or monitoring life
threatening diseases such as acquired immune deficiency syndrome
(AIDS), chronic or active hepatitis, tuberculosis, or myocardial
infarction, or to monitor therapy; is intended to assess the risk of
cardiovascular diseases; is intended for use in diabetes management; is
intended to identify or infer the identity of a microorganism directly
from clinical material; is intended for detection of antibodies to
microorganisms other than immunoglobulin G (IgG) and IgG assays when
the results are not qualitative, or are used to determine immunity, or
the assay is intended for use in matrices other than serum or plasma;
uses noninvasive testing; is intended for near-patient testing (point
of care).
Class II devices incorporating such changes or modifications are
not exempt from premarket notification because FDA has determined that
premarket notification is necessary to assure the safety and
effectiveness of the device.
In addition to the general limitation on exemptions that applies to
all class II devices that are described previously, FDA may limit the
exemption from premarket notification requirements to certain devices
within a generic class. For example, FDA, in section IV of this
document, is listing the exemption of the biofeedback device, but
limits the exemption to prescription battery powered devices that are
indicated for relaxation training and muscle reeducation. All other
biofeedback devices are still subject to premarket notification
requirements because FDA determined that premarket notification was
necessary to provide a reasonable assurance of safety and effectiveness
for these devices.
FDA advises, additionally, that an exemption from the requirement
of premarket notification does not mean that the device is exempt from
any other statutory or regulatory requirements, unless such exemption
is explicitly provided by order or regulation. Indeed, FDA's
determination that premarket notification was unnecessary to provide a
reasonable assurance of safety and effectiveness for devices listed in
this document is based, in part, on the assurance of safety and
effectiveness that other regulatory controls, such as current good
manufacturing practice requirements, provide.
Persons with pending 510(k) submissions for devices that are
exempted in this document, subject to the limitations on exemptions,
should withdraw their submissions.

IV. List of Class II Devices Exempted

FDA is identifying the following devices as class II devices that,
as of the date of publication of this document, are exempt from the
requirement to submit a premarket notification under section 510(k) of
the act, subject to limitations on exemptions in this document:

[[Page 3144]]

Table 1.--Exempted Class II Devices
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21 CFR Sections Name of Devices
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862.1440.............. Lactate dehydrogenase test system
862.1635.............. Total protein test system
864.6100.............. Bleeding time device
864.6400.............. Hematocrit measuring device
864.9160.............. Blood group substances of nonhuman origin for in vitro diagnostic use
864.9550.............. Lectins and protectins
864.9575.............. Environmental chamber for storage of platelet concentrate
864.9600.............. Potentiating media for in vitro diagnostic use
864.9700.............. Blood storage refrigerator and blood storage freezer
866.3060.............. Blastomyces dermatitidis serological reagents
866.3085.............. Brucella spp. serological reagents
866.3135.............. Coccidioides immitis serological reagents
866.3165.............. Cryptococcus neoformans serological reagents
866.3220.............. Entamoeba histolytica serological reagents
866.3280.............. Francisella tularensis serological reagents
866.3300.............. Haemophilus spp. serological reagents
866.3320.............. Histoplasma capsulatum serological reagents
866.3350.............. Leptospira spp. serological reagents
866.3415.............. Pseudomonas spp. serological reagents
866.3460.............. Rabiesvirus immunofluorescent reagents
866.3550.............. Salmonella spp. serological reagents
866.3660.............. Shigella spp. serological reagents
866.3930.............. Vibrio cholerae serological reagents
866.5040.............. Albumin immunological test system
866.5210.............. Ceruloplasmin immunological test system
866.5320.............. Properdin factor B immunological test system
866.5380.............. Free secretory component immunological test system
866.5460.............. Haptoglobin immunological test system
866.5470.............. Hemoglobin immunological test system
866.5490.............. Hemopexin immunological test system
876.1620.............. Urodynamics measurement system
876.1800.............. Urinev flow or volume measuring system
876.2040.............. Enuresis alarm
876.4370.............. Gastroenterlogy-urology evacuator
876.4650.............. Water jet renal stone dislodger system
876.4680.............. Uretal stone dislodger
876.4890(b)(1)........ Urological table and accessories
876.5250(b)(1)........ Urine collector and accessories
880.2200.............. Liquid crystal forehead temperature strip
880.2920.............. Clinical mercury thermometer
880.5100.............. AC-powered adjustable hospital bed
880.5140.............. Pediatric hospital bed
880.5475.............. Jet lavage
880.5500.............. AC-powered patient lift
880.5550.............. Alternating pressure air flotation mattress
880.6740.............. Vacuum-powered body fluid suction apparatus
880.6775.............. Powered patient transfer device
880.6910.............. Wheeled stretcher
882.5050.............. Biofeedback device^{1
886.3100.............. Ophthalmic tantalum clip
886.3130.............. Ophthalmic conformer
886.3800.............. Scleral shell
890.1925.............. Isokinetic testing and evaluation system
890.3500.............. External assembled lower limb prosthesis
890.3710.............. Powered communication system
890.3725.............. Powered environmental control system
890.5160.............. Air-fluidized bed
890.5170.............. Powered flotation therapy bed
890.5225.............. Powered patient rotation bed
890.5720.............. Water circulating hot or cold pack
890.5740.............. Powered heating pad
892.1980.............. Radiologic table
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\1\ Exemption is limited to prescription battery powered devices that are indicated for relaxation training and
muscle reeducation and prescription use.

V. Additional Exemptions

Under section 510(m)(2) of the act, as described previously,
interested persons may request that FDA exempt any class II device from
the premarket notification requirements. The request should identify
the generic type of device by the CFR section number (e.g., 21 CFR
884.1234) and state clearly why the submitter believes the factors
described in section II of this document apply, and that premarket
notification requirements

[[Page 3145]]

are not necessary to provide reasonable assurance of the safety and
effectiveness of the device. By February 19, 1998, FDA will provide
guidance on how to request such an exemption.

Dated: January 15, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-1485 Filed 1-16-98; 12:00 pm]
BILLING CODE 4160-01-F}