[Federal Register Volume 65, Number 111 (Thursday, June 8, 2000)]
[Rules and Regulations]
[Pages 36324-36326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-14462]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 880

[Docket No. 98N-0786]


General Hospital and Personal Use Devices; Classification of 
Liquid Chemical Sterilants/High Level Disinfectants and General Purpose 
Disinfectants

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying liquid 
chemical sterilants/high level disinfectants intended for use as the 
terminal step in processing critical and semicritical medical devices 
prior to patient use into class II (special controls), and general 
purpose disinfectants intended to process noncritical medical devices 
and equipment surfaces into class I (general controls). FDA is also 
exempting the general purpose disinfectants from the premarket 
notification requirements. This action is being taken under the Federal 
Food, Drug, and Cosmetic Act (the act), as amended by the Medical 
Device Amendments of 1976 (the 1976 amendments), the Safe Medical 
Devices Act of 1990 (the SMDA), and the Food and Drug Administration 
Modernization Act of 1997 (the FDAMA).

DATES: This rule is effective July 10, 2000.

FOR FURTHER INFORMATION CONTACT: Chiu S. Lin, Center for Devices and 
Radiological Health (CDRH) (HFZ-480), Food and Drug Administration, 
9200 Corporate Blvd., Rockville, MD 20850, 301-443-8913.

SUPPLEMENTARY INFORMATION:

I. Background

    The act (21 U.S.C. 301 et seq.), as amended by the 1976 amendments 
(Public Law 94-295), the SMDA (Public Law 101-629), and the FDAMA 
(Public Law 105-115), established a comprehensive system for the 
regulation of medical devices intended for human use. Section 513 of 
the act (21 U.S.C. 360c) established three categories (classes) of 
devices, depending on the regulatory controls needed to provide 
reasonable assurance of their safety and effectiveness. The three 
categories of devices are class I (general controls), class II (special 
controls), and class III (premarket approval).
    Under section 513 of the act, devices that were in commercial 
distribution before May 28, 1976 (the date of enactment of the 1976 
amendments), generally referred to as preamendments devices, are 
classified after FDA has: (1) Received a recommendation from a device 
classification panel (an FDA advisory committee); (2) published the 
panel's recommendation for comment, along with a proposed regulation 
classifying the device; and (3) published a final regulation 
classifying the device. FDA has classified most preamendments devices 
under these procedures.
    Devices that were not in commercial distribution prior to May 28, 
1976, generally referred to as postamendments devices, are classified 
automatically by statute (section 513(f) of the act (21 U.S.C. 
360c(f))) into class III without any FDA rulemaking process. Those 
devices remain in class III and require premarket approval, unless and 
until: (1) The device is reclassified into class I or II; (2) FDA 
issues an order classifying the device into class I or II in accordance 
with new section 513(f)(2) of the act, as amended by the FDAMA; or (3) 
FDA issues an order finding the device to be substantially equivalent, 
in accordance with section 513(i) of the act, to a predicate device 
that does not require premarket approval. The agency determines whether 
new devices are substantially equivalent to previously offered devices 
by means of premarket notification procedures in section 510(k) of the 
act (21 U.S.C. 360(k)) and 21 CFR part 807 of the regulations.
    A preamendments device that has been classified into class III may 
be marketed, by means of premarket notification procedures, without 
submission of a premarket approval application (PMA) until FDA issues a 
final regulation under section 515(b) of the act (21 U.S.C. 360e(b)) 
requiring premarket approval.
    Consistent with the act and the regulations, FDA consulted with the 
General Hospital and Personal Use Devices Panel (the Panel), an FDA 
advisory committee, regarding the classification of these devices.
    The FDAMA added a new section 510(l) to the act. New section 510(l) 
of the act provides that a class I device is exempt from the premarket 
notification requirements under section 510(k) of the act, unless the 
device is intended for a use which is of substantial importance in 
preventing impairment of human health or it presents a potential 
unreasonable risk of illness or injury. Hereafter, these are referred 
to as ``reserved criteria.'' FDA has considered the general purpose 
disinfectants in accordance with the reserved criteria and determined 
that these devices do not require premarket notification. Such an 
exemption permits manufacturers to introduce into commercial 
distribution generic types of devices without first submitting a 
premarket notification to FDA.

II. Regulatory History of the Device

    In the Federal Register of November 6, 1998 (63 FR 59917), FDA 
proposed to classify both liquid chemical sterilants intended for use 
as the terminal step in processing critical and semicritical medical 
devices prior to patient use into class II and general purpose 
disinfectants intended to process noncritical medical devices and 
equipment surfaces into class I. In the same issue of the Federal 
Register, FDA proposed to exempt the general purpose disinfectants from 
the premarket notification requirements. FDA recognizes a ``high level 
disinfectant'' as a potential separate or subordinate condition of use 
of a sterilant and has included it in the final rule to clarify its 
classification status. Initially, interested persons were given until 
February 4, 1999, to comment on the proposed regulation. Subsequently, 
FDA extended the comment period to March 8, 1999, in response to an 
extension request.

[[Page 36325]]

    FDA received one comment on the proposed rule from a non-profit 
trade association.

III. Summary of Final Rule

    As required by 21 CFR 860.84(g)(1) of the regulations, FDA is 
classifying liquid chemical sterilants/high level disinfectants into 
class II with the following special controls: The 510(k) guidance 
document (Ref. 1) and user information and training. FDA is also 
classifying general purpose disinfectants into class I and exempting 
these devices from premarket notification.
    Persons interested in obtaining a copy of the guidance (Ref. 1) may 
do so using the Internet. CDRH maintains an entry on the Internet for 
easy access to information including text, graphics, and files that may 
be downloaded to a personal computer with access to the Internet. The 
CDRH home page may be accessed at http://www.fda.gov/cdrh. ``Guidance 
on the Content and Format of Premarket Notification (510(k)) 
Submissions for Liquid Chemical Sterilants/High Level Disinfectants'' 
available at http://www.fda.gov/cdrh/ode/397.pdf.

IV. Analysis of Comment and FDA's Response

    The one comment FDA received requested that general purpose 
disinfectants, in addition to being exempt from the premarket 
notification procedures, also be exempt from the good manufacturing 
practice (GMP) requirements set forth in the Quality System Regulation 
(21 CFR part 820). The comment stated that general purpose 
disinfectants should be exempt from the GMP requirements because the 
Environmental Protection Agency (EPA) and state controls on them are 
sufficient to assure their quality for commercial distribution.
    FDA disagrees with the comment. The agency recognizes the dual 
regulatory functions and responsibilities of the FDA and EPA, but the 
functions and responsibilities of these agencies address different 
aspects of the product. Because of the continued classification of the 
general purpose disinfectants as a medical device, they remain subject 
to the GMP requirements of the act.
    General purpose disinfectants are also regulated by EPA as 
environmental pesticides under the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA). The EPA controls (EPA product registration, 
Good Laboratory Practices, State registration and testing, maintenance 
of records, and EPA establishment registration) focus on the quality 
and integrity of pesticide data. Although some States have programs 
regulating the sale and use of general purpose disinfectants as 
pesticides, not all States have adopted the same enforcement programs. 
This lack of uniformity does not provide the additional safeguard 
needed for the national use of these products for disinfection of 
medical devices.
    Therefore, under section 513 of the act, FDA is adopting the 
summary of reasons for the Panel's recommendation and the summary of 
data upon which the Panel's recommendation is based, in their entirety. 
FDA also agrees with the assessment of the risks to public health 
stated in the proposed rule published on November 6, 1998. FDA is 
issuing this final rule, which classifies these generic types of 
devices as follows: Liquid chemical sterilants/high level disinfectants 
into class II and general purpose disinfectants into class I.

V. Reference

    The following reference has been placed on display in the Dockets 
Management Branch (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852, and may be seen by interested persons between 9 a.m. and 4 p.m., 
Monday through Friday.
    1. FDA, Center for Devices and Radiological Health, Office of 
Device Evaluation, ``Guidance on the Content and Format of Premarket 
Notification (510(k)) Submissions for Liquid Chemical Sterilants/High 
Level Disinfectants,'' January 3, 2000.

VI. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) 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.

VII. 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 Enforcement 
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. The classification of these devices formalizes the 
current process for the class I and II devices. For the class I 
devices, FDA is not adding any additional burden, because they are 
effectively regulated as class I devices now. For the class II devices, 
they are in compliance with the guidance. The agency therefore 
certifies that this final rule will not have a significant economic 
impact on a substantial number of small entities. In addition, this 
final rule will not impose costs of $100 million or more on either the 
private sector or State, local, and tribal governments in the aggregate 
and, therefore a summary statement or analysis under section 202(a) of 
the Unfunded Mandates Reform Act of 1995 is not required.

VIII. Paperwork Reduction Act of 1995

    FDA concludes that this final rule contains no information that is 
subject to review by the Office of Management and Budget under the 
Paperwork Reduction Act of 1995. The special controls do not require 
the respondent to submit additional information to the public.

List of Subjects in 21 CFR Part 880

    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 
880 is amended as follows:

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

    1. The authority citation for 21 CFR part 880 continues to read as 
follows:


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

    2. Section 880.6885 is added to subpart G to read as follows:


Sec. 880.6885  Liquid chemical sterilants/high level disinfectants.

    (a) Identification. A liquid chemical sterilant/high level 
disinfectant is a germicide that is intended for use as the terminal 
step in processing critical and semicritical medical devices prior to 
patient use. Critical devices make contact with normally sterile tissue 
or

[[Page 36326]]

body spaces during use. Semicritical devices make contact during use 
with mucous membranes or nonintact skin.
    (b) Classification. Class II (special controls). Guidance on the 
Content and Format of Premarket Notification (510(k)) Submissions for 
Liquid Chemical Sterilants/High Level Disinfectants, and user 
information and training.
    3. Section 880.6890 is added to subpart G to read as follows:


Sec. 880.6890  General purpose disinfectants.

    (a) Identification. A general purpose disinfectant is a germicide 
intended to process noncritical medical devices and equipment surfaces. 
A general purpose disinfectant can be used to preclean or decontaminate 
critical or semicritical medical devices prior to terminal 
sterilization or high level disinfection. Noncritical medical devices 
make only topical contact with intact skin.
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 880.9.

    Dated: May 23, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-14462 Filed 6-7-00; 8:45 am]
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