[Federal Register: November 15, 2002 (Volume 67, Number 221)]
[Rules and Regulations]
[Page 69119-69121]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15no02-1]
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Rules and Regulations
Federal Register
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[[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.
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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]
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