[Federal Register: September 16, 2002 (Volume 67, Number 179)]
[Rules and Regulations]
[Page 58328-58329]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16se02-8]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 862
[Docket Nos. 01P-0119 and 01P-0235]
Clinical Chemistry and Clinical Toxicology Devices;
Reclassification of Cyclosporine and Tacrolimus Assays
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is reclassifying
cyclosporine and tacrolimus assays from class III (premarket approval)
to class II (special controls). These assays are used as an aid in the
management of transplant patients receiving these drugs. FDA is also
identifying the guidance document entitled ``Class II Special Controls
Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for
Industry and FDA'' as the special control the agency believes will
reasonably ensure the safety and effectiveness of these devices. This
reclassification is being taken after a review of petitions submitted
by Dade Behring, Inc., and Microgenics, Inc. The agency is taking this
action 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 (FDAMA). Elsewhere in this
issue of the Federal Register, FDA is announcing the availability of a
class II special controls guidance entitled ``Class II Special Controls
Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for
Industry and FDA.''
DATES: This rule is effective October 16, 2002.
FOR FURTHER INFORMATION CONTACT: Jean M. Cooper, Center for Devices
and Radiological Health (HFZ-440), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD, 20850, 301-594-1243.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of February 21, 2002 (67 FR 7982), FDA
published a proposed rule to reclassify cyclosporine and tacrolimus
assays after reviewing information contained in reclassification
petitions submitted by Dade Behring, Inc., and Microgenics, Inc. FDA
identified the guidance document entitled ``Class II Special Controls
Guidance Document: Cyclosporine and Tacrolimus Assays; Draft Guidance
for Industry and FDA'' as the special control capable of providing
reasonable assurance of safety and effectiveness for these devices.
These assays are used as an aid in the management of transplant
patients receiving these drugs. Interested persons were invited to
comment on the proposed rule by April 22, 2002. FDA received two
comments that were supportive of its proposed reclassification, but the
comments suggested specific recommendations for changes to the
guidance.
II. FDA's Conclusions
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 the special controls, in
conjunction with general controls, provide reasonable assurance of the
safety and effectiveness of these devices. Elsewhere in this issue of
the Federal Register, FDA is announcing the availability of the
guidance document. The guidance document was revised to reflect
consideration of the comments received. Following the effective date of
this final classification rule, any firm submitting a 510(k) premarket
notification for a cyclosporine or tacrolimus test system will need to
address the issues covered in the special
[[Page 58329]]
control guidance. However, the firm need only show that its device
meets the recommendations of the guidance or in some other way provides
equivalent assurances of safety and effectiveness.
FDA is now codifying the classification and the special control
guidance document for cyclosporine and tacrolimus test systems by
adding new Sec. Sec. 862.1235 and 862.1678. For the convenience of the
reader, FDA is also adding a new Sec. 862.1(d) to inform the reader
where to find guidance documents referenced in part 862.
III. 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.
IV. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (Public Law 96-354) (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 cyclosporine and tacrolimus
assays from class III to class II will relieve manufacturers of the
cost of complying with the premarket approval requirements in section
515 of the act. Furthermore, the special controls guidance document
does not impose any new burdens on manufacturers; it advises
manufacturers about ways to comply with the special controls that allow
the agency to down classify these devices. By eliminating the need for
premarket approval applications, reclassification will reduce
regulatory costs with respect to these devices, impose no significant
economic impact on any small entities, and 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.
V. 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.
VI. Paperwork Reduction Act of 1995
FDA concludes that this final rule contains no new collections of
information. Therefore, clearance by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 is not required.
List of Subjects in 21 CFR Part 862
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
862 is amended as follows:
PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
1. The authority citation for 21 CFR part 862 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
2. Section 862.1 is amended by adding new paragraph (d) to read as
follows:
Sec. 862.1 Scope.
* * * * *
(d) Guidance documents referenced in this part are available on the
Internet at http://www.fda.gov/cdrh/guidance.html.
3. Section 862.1235 is added to subpart B to read as follows:
Sec. 862.1235 Cyclosporine test system.
(a) Identification. A cyclosporine test system is a device intended
to quantitatively determine cyclosporine concentrations as an aid in
the management of transplant patients receiving therapy with this drug.
This generic type of device includes immunoassays and chromatographic
assays for cyclosporine.
(b) Classification. Class II (special controls). The special
control is ``Class II Special Controls Guidance Document: Cyclosporine
and Tacrolimus Assays; Guidance for Industry and FDA.'' See Sec.
862.1(d) for the availability of this guidance document.
4. Section 862.1678 is added to subpart B to read as follows:
Sec. 862.1678 Tacrolimus test system.
(a) Identification. A tacrolimus test system is a device intended
to quantitatively determine tacrolimus concentrations as an aid in the
management of transplant patients receiving therapy with this drug.
This generic type of device includes immunoassays and chromatographic
assays for tacrolimus.
(b) Classification. Class II (special controls). The special
control is ``Class II Special Controls Guidance Document: Cyclosporine
and Tacrolimus Assays; Guidance for Industry and FDA.'' See Sec.
862.1(d) for the availability of this guidance document.
Dated: August 19, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-23508 Filed 9-13-02; 8:45 am]
BILLING CODE 4160-01-S