[Federal Register: December 8, 2000 (Volume 65, Number 237)]
[Rules and Regulations]
[Page 76930-76932]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08de00-5]
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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