[Federal Register Volume 65, Number 202 (Wednesday, October 18, 2000)]
[Rules and Regulations]
[Pages 62285-62286]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-26740]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 862

[Docket No. 00P-1280]


Medical Devices; Exemption From Premarket Notification; Class II 
Devices; Triiodothyronine Test System

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 a petition requesting exemption from the premarket 
notification requirements for the triiodothyronine test system with 
certain limitations. This rule will exempt from premarket notification 
the triiodothyronine test system intended for measuring the hormone 
triiodothyronine in serum and plasma. FDA is publishing this order in 
accordance with procedures established by the Food and Drug 
Administration Modernization Action of 1997 (FDAMA).

DATES: This rule is effective October 18, 2000.

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, and 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. The 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 (Public Law 94-295)), as amended by the Safe Medical Devices 
Act of 1990 (the SMDA (Public Law 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 ensure 
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 that 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 
(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 (Public 
Law 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 Internet 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. Petition

    On April 26, 2000, FDA received a petition requesting an exemption 
from premarket notification for the triiodothyronine test system. The 
triiodothyronine test system is currently classified under 21 CFR 
862.1710. In the Federal Register of July 11, 2000 (65 FR 42706), FDA 
published a notice announcing that this petition had been received and 
provided an opportunity for interested persons to submit comments on 
the petition by August 10, 2000. FDA received no comments. FDA has 
reviewed the petition and has determined that the triiodothyronine test 
system intended for measuring the hormone triiodothyronine in serum and 
plasma does meet the criteria for exemption from the notification 
requirements. This is the only type of triiodothyronine test system of 
which FDA presently has any knowledge. The exemption is limited to 
triiodothyronine test systems of the type described and is also subject 
to the general limitations on exemptions from premarket notification 
for clinical chemistry and clinical toxicology devices as described in 
21 CFR 870.9. For example, the exemption will not apply to devices of 
this type that present new indications, novel designs, or alternative 
materials. The exemption also will not apply if the

[[Page 62286]]

device is intended for over-the-counter use.

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 (Public Law 104-121)), and the Unfunded Mandates Reform Act of 
1995 (Public Law 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.
    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.

VII. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the order and, consequently, a federalism 
summary impact statement is not required.

List of Subjects in 21 CFR Part 862

    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 
862 is 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 862.1710 is amended by revising paragraph (b) to read as 
follows:


Sec. 862.1710  Total triiodothyronine test system.

* * * * *
    (b) Classification. Class II. This 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.

    Dated: October 12, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-26740 Filed 10-17-00; 8:45 am]
BILLING CODE 4160-01-F