[Federal Register Volume 65, Number 237 (Friday, December 8, 2000)]
[Rules and Regulations]
[Pages 76930-76932]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-31292]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. 00P-1343]


Medical Device; Exemption From Premarket Notification; Class II 
Devices; Barium Enema Retention Catheters and Tips With or Without a 
Bag

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 barium enema retention catheters and tips 
with or without a bag with certain limitations. This rule will exempt 
from premarket notification barium enema retention catheters and tips 
with or without a bag. FDA is publishing this order in accordance with 
procedures established by the Food and Drug Administration 
Modernization Act of 1997 (FDAMA).

DATES: This rule is effective December 8, 2000.

[[Page 76931]]


FOR FURTHER INFORMATION CONTACT: Linda L. Dart, Center for Devices and 
Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1220.

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 (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 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 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) of the act, 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 that 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 June 13, 2000, FDA received a petition requesting an exemption 
from premarket notification for the barium enema retention catheters 
and tips with or without a bag. Barium enema retention catheters and 
tips with or without a bag are currently classified under 21 CFR 
876.5980 as a gastrointestinal tube and accessory. In the Federal 
Register of August 8, 2000 (65 FR 48527), FDA published a notice 
announcing that this petition had been received and providing 
opportunity for interested persons to submit comments on the petition 
by September 7, 2000. FDA received no comments. FDA has reviewed the 
petition and has determined that barium enema retention catheters and 
tips with or without a bag used as a gastrointestinal tube and 
accessory meet the criteria for exemption from the notification 
requirements. The exemption is limited to barium enema retention 
catheters and tips with or without a bag, as described, and is also 
subject to the general limitations on exemptions from premarket 
notification for therapeutic devices as described in 21 CFR 876.9. FDA 
also notes that all latex containing devices, including barium enema 
retention catheters and tips with or without a bag, and other devices 
that are exempt from the premarket notification requirements of the 
act, are subject to the labeling regulation found in 21 CFR 801.437 
(User labeling for devices that contain natural rubber).

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.

[[Page 76932]]

    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 rules 
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 rules 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 876

    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 
876 is amended as follows:

PART 876--GASTROENTEROLOGY--UROLOGY DEVICES

    1. The authority citation for 21 CFR part 876 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


    2. Section 876.5980 is amended by revising paragraph (b)(1) to read 
as follows:


Sec. 876.5980  Gastrointestinal tube and accessories.

* * * * *
    (b) Classification. (1) Class II (special controls). The barium 
enema retention catheter and tip with or without a bag that is a 
gastrointestinal tube and accessory is exempt from the premarket 
notification procedures in subpart E of this part subject to the 
limitations in Sec. 876.9.
* * * * *

    Dated: December 3, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-31292 Filed 12-7-00; 8:45 am]
BILLING CODE 4160-01-F