[Federal Register Volume 64, Number 5 (Friday, January 8, 1999)]
[Rules and Regulations]
[Pages 1123-1125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-380]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 862 and 892
[Docket Nos. 98P-0506 and 98P-0621]
Medical Devices; Exemptions From Premarket Notification; Class II
Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is publishing an order
granting petitions requesting exemption from the premarket notification
requirements for certain class II devices. FDA is publishing this order
in accordance with procedures established by the Food and Drug
Administration Modernization Act of 1997 (FDAMA).
EFFECTIVE DATE: January 8, 1999.
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 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
[[Page 1124]]
807, require persons who intend to market a new device to submit a
premarket notification report (510(k)) 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.
On November 21, 1997, the President signed into law FDAMA (Pub. L.
105-115). Section 206 of 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 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 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. FDA published that
list in the Federal Register of January 21, 1998 (63 FR 3142).
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 regarding the
exemption of the device that was the subject of the notice. 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
There are a number of factors FDA may consider to determine whether
a 510(k) is necessary to provide reasonable assurance of the safety and
effectiveness of a class II device. These factors are discussed in the
guidance the agency issued on February 19, 1998, entitled ``Procedures
for Class II Device Exemptions from Premarket Notification, Guidance
for Industry and CDRH Staff.'' That guidance can be obtained through
the World Wide Web on the CDRH home page at ``http://www.fda.gov/cdrh''
or by facsimile through CDRH Facts-on-Demand at 1-800-899-0381 or 301-
827-0111. Specify ``159'' when prompted for the document shelf number.
III. Petitions
FDA has received the following petitions requesting an exemption
from premarket notification for class II devices:
1. Abbott Laboratories, 21 CFR 862.1715, triiodothyronin uptake
test system devices.
2. Radiological Imaging Technology, 21 CFR 892.5050, film dosimetry
system, a.k.a. film scanning system.
In the Federal Register of September 30, 1998 (63 FR 52275), FDA
published a notice announcing that these petitions had been received
and providing an opportunity for interested persons to submit comments
on the petitions by October 30, 1998. FDA received no comments. FDA has
reviewed these petitions and has determined that these devices meet the
criteria for exemption described previously and is, therefore, issuing
this order exempting these devices from the requirements of premarket
notification and is codifying this order in the Code of Federal
Regulations (CFR). The film dosimetry system is an accessory to the
medical charged-particle radiation therapy system classified in 21 CFR
892.5050. The exemption for the film dosimetry system is limited only
to film dosimetry systems intended for use as a quality control system.
(See 21 CFR 892.9 for further information on limitations on exemptions
for radiological devices.)
IV. Environmental Impact
The agency has determined under 21 CFR 25.30(h) 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.
V. 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), as
amended by subtitle D of the Small Business Regulatory Fairness Act of
1996 (Pub. L. 104-121) and the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4). 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.
If a rule has a significant economic impact on a substantial number
of small entities, the Regulatory Flexibility Act requires agencies to
analyze regulatory options that would minimize any significant impact
of a rule on small entities. Because this rule will relieve a burden
and simplify the marketing of these devices, the agency 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.
VI. Paperwork Reduction Act of 1995
FDA concludes that this final rule contains no collections of
information. Therefore, clearance by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 is not required.
List of Subjects
21 CFR Part 862
Medical devices.
21 CFR Part 892
Medical devices, Radiation protection, X-rays.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
862 and 892 are amended as follows:
PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
1. The authority citation for 21 CFR part 862 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
2. Section 862.1715 is amended by revising paragraph (b) to read as
follows:
Sec. 862.1715 Triiodothyronine uptake test system.
* * * * *
(b) Classification. Class II. The device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in Sec. 862.9.
PART 892--RADIOLOGY DEVICES
3. The authority citation for 21 CFR part 892 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
4. Section 892.5050 is amended by revising paragraph (b) to read as
follows:
[[Page 1125]]
Sec. 892.5050 Medical charged-particle radiation therapy system.
* * * * *
(b) Classification. Class II. When intended for use as a quality
control system, the film dosimetry system (film scanning system)
included as an accessory to the device described in paragraph (a) of
this section, is exempt from the premarket notification procedures in
subpart E of part 807 of this chapter subject to the limitations in
Sec. 892.9.
Dated: December 22, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 99-380 Filed 1-7-99; 8:45 am]
BILLING CODE 4160-01-F
