[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