[Federal Register Volume 66, Number 221 (Thursday, November 15, 2001)]
[Rules and Regulations]
[Pages 57368-57369]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-28563]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 892

[Docket No. 01N-0238]


Medical Devices; Exemptions From Premarket Notification; Class II 
Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is publishing a final 
rule exempting from the premarket notification requirements the 
fluoroscopic compression device, a manual compression device that 
allows a radiologist to press on the abdomen during a fluoroscopic 
procedure without exposing his or her hand to the x-ray beam. The 
device is classified as an accessory to the image-intensified 
fluoroscopic x-ray system. FDA received a petition requesting an 
exemption for the F-Spoon device, a type of fluoroscopic manual 
compression device. FDA is expanding the exemption for this type of 
generic device to include other fluoroscopic compression devices. FDA 
is publishing this order in accordance with the Food and Drug 
Administration Modernization Act of 1997 (FDAMA).

DATES: This rule is effective December 17, 2001.

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 (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

[[Page 57369]]

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 March 25, 2001, FDA received a petition requesting an exemption 
from premarket notification for the F-Spoon, a manual compression 
device that allows a radiologist to press on the abdomen during a 
fluoroscopic procedure without exposing his or her hand to the x-ray 
beam. In the Federal Register of June 18, 2001 (66 FR 32828), 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 July 18, 2001. FDA also announced that it intended to 
expand the exemption to include all fluoroscopic compression devices of 
this generic type, subject to limitations in 21 CFR 892.9. FDA received 
no comments. FDA has reviewed the petition and has determined that this 
device meets the criteria for exemption described previously and is, 
therefore, issuing this order exempting the device from the 
requirements of premarket notification. The fluoroscopic compression 
device is an accessory to the image-intensified fluoroscopic x-ray 
system classified under 21 CFR 892.1650.

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 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 part 
892 is amended as follows:

PART 892--RADIOLOGY DEVICES

    1. The authority citation for 21 CFR part 892 continues to read as 
follows:

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

    2. Section 892.1650 is amended by revising paragraph (b) to read as 
follows:


Sec. 892.1650  Image-intensified fluoroscopic x-ray system.

* * * * *
    (b) Classification. Class II. When intended as an accessory to the 
device described in paragraph (a) of this section, the fluoroscopic 
compression device is exempt from the premarket notification procedures 
in subpart E of part 807 of this chapter subject to Sec. 892.9.

    Dated: October 25, 2001.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 01-28563 Filed 11-14-01; 8:45 am]
BILLING CODE 4160-01-S