[Federal Register Volume 67, Number 9 (Monday, January 14, 2002)]
[Rules and Regulations]
[Pages 1606-1607]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-792]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 864

[Docket No. 95P-0315]


Hematology and Pathology Devices; Reclassification of the 
Automated Differential Cell Counter

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is reclassifying the 
automated differential cell counter (ADCC) from class III (premarket 
approval) into class II (special controls). FDA is also identifying the 
guidance document entitled ``Class II Special Controls Guidance 
Document: Premarket Notifications for Automated Differential Cell 
Counters for Immature or Abnormal Blood Cells; Final Guidance for 
Industry and FDA'' as the special control that the agency believes will 
reasonably ensure the safety and effectiveness of the device. This 
reclassification is being undertaken based on new information submitted 
in a reclassification petition from the International Society for 
Laboratory Hematology (ISLH), under the Federal Food, Drug, and 
Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 
1990 and the FDA Modernization Act of 1997.

DATES: This rule is effective February 13, 2002.

ADDRESSES: Comments and the guidance may be seen at the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Larry J. Brindza, Center for Devices 
and Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-1293.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of May 9, 2001 (66 FR 23634), FDA published 
a proposed rule to reclassify the automated differential cell counter 
from class III (premarket approval) into class II (special controls) 
based on new information regarding this device and on the 
recommendation of the Hematology and Pathology Devices Panel. FDA also 
identified the document ``Guidance for Premarket Notification for 
Automated Differential Cell Counters for Immature or Abnormal Blood 
Cells'' as the special control capable of providing reasonable 
assurance of safety and effectiveness for this device. The agency has 
since revised the guidance to provide the option of submitting an 
abbreviated 510(k), thereby reducing the burden. At the same time, FDA 
is revising the title of the document to ``Class II Special Controls 
Guidance Document: Premarket Notifications for Automated Differential 
Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for 
Industry and FDA.''
    Interested persons were invited to comment on the proposed rule by 
August 7, 2001. FDA received one comment. That comment commended FDA's 
proposal to reclassify ADCCs into class II and agreed that the guidance 
proposed as the special control was adequate to provide reasonable 
assurance of the safety and effectiveness of the device.

II. FDA's Conclusion

    Based on a review of the available information, referenced in the 
preamble to the proposed rule and placed on file in FDA's Dockets 
Management Branch, FDA concludes that special controls, in conjunction 
with general controls, provide reasonable assurance of the safety and 
effectiveness of this device.

III. Electronic Access

    In order to receive ``Class II Special Controls Guidance Document: 
Premarket Notifications for Automated Differential Cell Counters for 
Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA'' 
via your fax machine, call the Center for Devices and Radiological 
Health (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 
access DSMICA Facts, at second voice prompt press 2, and then enter the 
document number (1184) followed by the pound sign (#). Then 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 a Web site at http://www.fda.gov/cdrh on the Internet for easy access to information including text, 
graphics, and files that may be downloaded to a personal computer. 
Updated on a regular basis, the CDRH Web site includes 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 
medical device-oriented information. The CDRH Web site also includes 
the document ``Class II Special Controls Guidance Document: Premarket 
Notifications for Automated Differential Cell Counters for Immature or 
Abnormal Blood Cells; Final Guidance for Industry and FDA'' which may 
be accessed at http://www.fda.gov/cdrh/ode/guidance/1184.html. A search 
capability for all guidance documents may be found at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also available 
at http://www.fda.gov/ohrms/dockets.

IV. 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.

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. Reclassification of ADCCs from class III will 
relieve all manufacturers of these devices of the cost of complying 
with the premarket approval requirements in section 515 of the act (21 
U.S.C. 360e).
    Moreover, compliance with special controls proposed for this device 
will not impose significant new costs on affected manufacturers because 
most of

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these devices already comply with the proposed special controls. 
Because reclassification will reduce regulatory costs with respect to 
ADCCs, it will impose no significant economic impact on any small 
entities, and it may permit small potential competitors to enter the 
marketplace by lowering their costs. 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 of analysis under section 202(a) of the Unfunded 
Mandates Reform Act of 1995 is not required.

VI. 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 Executive order and, consequently, a 
federalism summary impact statement is not required.

VII. 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 (44 U.S.C. 3501-3520) 
is not required.

List of Subjects in 21 CFR Part 864

    Biologics, Blood, Laboratories, Medical devices, Packaging and 
containers.

PART 864--HEMATOLOGY AND PATHOLOGY DEVICES

    1. The authority citation for 21 CFR part 864 continues to read as 
follows:

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

    2. Section 864.5220 is revised to read as follows:


Sec. 864.5220  Automated differential cell counter.

    (a) Identification. An automated differential cell counter is a 
device used to identify one or more of the formed elements of the 
blood. The device may also have the capability to flag, count, or 
classify immature or abnormal hematopoietic cells of the blood, bone 
marrow, or other body fluids. These devices may combine an electronic 
particle counting method, optical method, or a flow cytometric method 
utilizing monoclonal CD (cluster designation) markers. The device 
includes accessory CD markers.
    (b) Classification. Class II (special controls). The special 
control for this device is the FDA document entitled ``Class II Special 
Controls Guidance Document: Premarket Notifications for Automated 
Differential Cell Counters for Immature or Abnormal Blood Cells; Final 
Guidance for Industry and FDA.''

    Dated: January 3, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-792 Filed 1-11-02; 8:45 am]
BILLING CODE 4160-01-S