[Federal Register Volume 67, Number 221 (Friday, November 15, 2002)]
[Rules and Regulations]
[Pages 69119-69121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-28942]



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 Rules and Regulations
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  Federal Register / Vol. 67, No. 221 / Friday, November 15, 2002 / 
Rules and Regulations  

[[Page 69119]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 880

[Docket No. 01N-0339]


Medical Devices; Classification for Medical Washer and Medical 
Washer-Disinfector

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is classifying the 
medical washer and medical washer-disinfector intended for general 
medical purposes to clean and dry surgical instruments, decontaminate 
or disinfect anesthesia equipment, hollowware, and other medical 
devices into class II (special controls). FDA is also identifying the 
guidance document entitled ``Class II Special Controls Guidance 
Document: Medical Washers and Medical Washer-Disinfectors'' (the 
guidance) as the special control that, in addition to general controls, 
the agency believes will reasonably ensure the safety and effectiveness 
of the device. 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 December 16, 2002.

FOR FURTHER INFORMATION CONTACT: Chiu S. Lin, Center for Devices and 
Radiological Health (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) 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 this device.

II. Regulatory History of the Device

    In the Federal Register of February 7, 2002 (67 FR 5750), FDA 
proposed to classify the medical washer and medical washer-disinfector 
into class II (special controls). This device is intended for general 
medical purposes to clean and dry surgical instruments, decontaminate 
or disinfect anesthesia equipment, hollowware, and other medical 
devices.
    Interested persons were given until May 8, 2002 to comment on the 
proposed regulation.
    FDA received a total of three comments from one health 
professional, a consumer group, and one consumer. All three comments 
agreed with the proposed rule. In addition, one comment suggested that 
FDA require manufacturers to include testing to monitor cleaning 
efficacy.

III. Summary of Final Rule

    FDA believes that in order to reduce the potential for confusion, 
the identification terms ``general use'' washer and ``general use 
washer-disinfector'' as recommended by the Panel should be changed to 
``medical washer'' and ``medical washer-disinfector.'' The new terms 
will distinguish these devices from ``general purpose article'' washers 
and washer-disinfectors that are exempt from section 510(k) of the act 
requirements. FDA also believes that decontamination and disinfection 
are distinct intended uses that require FDA to distinguish washers from 
washer-disinfectors in classification descriptions.
    FDA concurred with the Panel that the medical washers and washer-
disinfectors should be classified into class II because special 
controls, in addition to general controls, would provide reasonable 
assurance of the safety and effectiveness of the device, and there is 
sufficient information to establish special controls to provide such 
assurance. FDA identified the guidance entitled ``Class II Special 
Controls Guidance Document: Medical

[[Page 69120]]

Washers and Medical Washer-Disinfectors'' as the special control for 
these devices. Following the effective date of this final 
classification rule, any firm submitting a section 510(k) of the act 
premarket notification for a medical washer or medical washer 
disinfector will need to address the issues covered in the special 
control guidance. However, the firm need only show that its device 
meets the recommendations of the guidance or in some other way provides 
equivalent assurance of safety and effectiveness.
    As the Panel initially recommended, FDA believes that the medical 
washer is exempt from section 510(k) of the act requirements and that 
some medical washer-disinfectors can also be exempt from section 510(k) 
of the act requirements, depending on intended use. The medical washer-
disinfector intended to clean and provide high level disinfection to 
medical devices should be subject to section 510(k) of the act 
requirements because the reusable devices subject to a high level 
disinfection process may pose a high risk of infection and other 
serious sequelae if the washer-disinfector is unsafe or ineffective. 
The medical washer-disinfector intended to clean and provide low or 
intermediate level disinfection can be exempt from 510(k) requirements 
because the reusable devices subject to low or intermediate 
disinfection pose a relatively lower risk of infection and other 
serious sequelae if the washer-disinfector is unsafe or ineffective.
    In order to receive the guidance entitled ``Class II Special 
Controls Guidance Document: Medical Washers and Medical Washer-
Disinfectors'' via your fax machine, call the CDRH Facts-on-Demand 
system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. At 
the first voice prompt press 1 to enter the system. At the second voice 
prompt press 1 to order a document. Enter the document number (1252) 
followed by the pound sign ([numsign]). Follow the remaining voice 
prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may also 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 Internet access. Updated on a 
regular basis, the CDRH home page includes the civil money penalty 
guidance documents package, device safety alerts, Federal Register 
reprints, information on premarket submissions (including lists of 
approved applications and manufacturers' addresses), small 
manufacturers' assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH home page may be accessed at http://www.fda.gov/cdrh. The document entitled ``Class II Special Controls Guidance 
Document: Medical Washer and Medical Washer-Disinfector'' is available 
on the Internet at http://www.fda.gov/cdrh/ode/guidance/1252.pdf.

IV. Analysis of Comments and FDA's Response

    FDA received three comments. All three comments agreed with the 
classification. One comment also suggested that FDA require 
manufacturers to include testing to monitor cleaning efficacy.
    Currently, there is no standard for validating cleaning efficacy. 
Manufacturers can include in their manuals recommendations for routine 
monitoring of cleaning efficacy and frequency of testing. The guidance 
document does not prevent them from doing this. Once standardized test 
methods are available, FDA will review and recognize those standardized 
test methods as appropriate.
    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 its entirety. 
FDA is also adopting the assessment of the risks to public health 
stated in the proposed rule published on February 7, 2002. Furthermore, 
FDA is issuing this final rule that classifies the generic type of 
device, medical washer and medical washer-disinfector into class II.

V. 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.

VI. 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), 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 special controls guidance document does not 
impose any new burdens on these or future manufacturers. It merely 
assures that, in the future, devices of this generic type will be at 
least as safe and effective as the presently marketed devices. These 
devices are already subject to premarket notification and labeling 
requirements. The guidance document merely advises manufacturers on 
appropriate means of complying with these requirements. 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.

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.

VIII. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520) is not 
required.
    The information collections addressed in the special control 
guidance document identified by this rule have

[[Page 69121]]

been approved by OMB in accordance with the PRA under the regulations 
governing premarket notification submissions, 21 CFR part 807, subpart 
E, OMB control number 0910-0120.

IX. Reference

    The following reference has been placed on display in the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. This reference may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Transcript of General Hospital and Personal Use Devices Panel of 
the Medical Devices Advisory Committee Meeting, September 14, 1998.

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 880.6991 is added to subpart G to read as follows:


Sec.  880.6991  Medical washer.

    (a) Identification. A medical washer is a device that is intended 
for general medical purposes to clean and dry surgical instruments, 
anesthesia equipment, hollowware, and other medical devices.
    (b) Classification. Class II (special controls). The special 
control for this device is the FDA guidance document entitled ``Class 
II Special Controls Guidance Document: Medical Washers and Medical 
Washer-Disinfectors.'' The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter 
subject to Sec.  880.9.
    3. Section 880.6992 is added to subpart G to read as follows:


Sec.  880.6992  Medical washer-disinfector.

    (a) Identification. A medical washer-disinfector is a device that 
is intended for general medical purposes to clean, decontaminate, 
disinfect, and dry surgical instruments, anesthesia equipment, 
hollowware, and other medical devices.
    (b) Classification. Class II (special controls). The special 
control for this device is the FDA guidance document entitled ``Class 
II Special Controls Guidance Document: Medical Washers and Medical 
Washer-Disinfectors.''
    (1) Medical washer-disinfectors that are intended to clean, high 
level disinfect, and dry surgical instruments, anesthesia equipment, 
hollowware, and other medical devices.
    (2) Medical washer-disinfectors that are intended to clean, low or 
intermediate level disinfect, and dry surgical instruments, anesthesia 
equipment, hollowware, and other medical devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this 
chapter subject to Sec.  880.9.

    Dated: October 28, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-28942 Filed 11-14-02; 8:45 am]
BILLING CODE 4160-01-S