[Federal Register Volume 63, Number 3 (Tuesday, January 6, 1998)]
[Notices]
[Pages 565-566]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-153]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97M-0520]
Abbott Laboratories, Premarket Approval of IMx
Tacrolimus II Assay
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing its
approval of the application submitted by Abbott Laboratories, Abbott
Park, IL, for premarket approval, under the Federal Food, Drug, and
Cosmetic Act (the act), of the IMx Tacrolimus II Assay. FDA's
Center for Devices and Radiological Health (CDRH) notified the
applicant, by letter of August 26, 1997, of the approval of the
application.
DATES: Petitions for administrative review by February 5, 1998.
ADDRESSES: Written requests for copies of the summary of safety and
effectiveness data and petitions for administrative review to the
Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Steven I. Gutman, Center for Devices
and Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 301-594-1243.
SUPPLEMENTARY INFORMATION: On February 18, 1997, Abbott Laboratories,
Abbott Park, IL 60064-3537, submitted to CDRH an application for
premarket approval of the IMx Tacrolimus II Assay. The device
is an in vitro reagent system for the quantitative determination of
tacrolimus and some metabolites in human whole blood as an aid in the
management of liver allograft patients receiving tacrolimus therapy.
In accordance with the provisions of section 515(c)(2) of the act
(21 U.S.C. 360e(c)(2)) as amended by the Safe Medical Devices Act of
1990, this premarket approval application (PMA) was not referred to the
Clinical Chemistry and Toxicology Devices Panel of the Medical Devices
Advisory Committee, an FDA advisory committee, for review and
recommendation because the information in the PMA substantially
duplicates information previously reviewed by this panel.
On August 26, 1997, CDRH approved the application by a letter to
the applicant from the Deputy Director, Clinical and Review Policy, the
Office of Device Evaluation, CDRH.
A summary of the safety and effectiveness data on which CDRH based
its approval is on file in the Dockets Management Branch (address
above) and is available from that office upon written request. Requests
should be identified with the name of the device and the docket number
found in brackets in the heading of this document.
Opportunity for Administrative Review
Section 515(d)(3) of the act authorizes any interested person to
petition, under section 515(g) of the act, for administrative review of
CDRH's decision to approve this application. A petitioner may request
either a formal hearing under 21 CFR part 12 of FDA's administrative
practices and procedures regulations or a review of the application and
CDRH's action by an independent advisory committee of experts. A
petition is to be in the form of a petition for reconsideration under
21 CFR 10.33(b). A petitioner shall identify the form of review
requested (hearing or independent advisory committee) and shall submit
with the petition supporting data and information showing that there is
a genuine and substantial issue of material fact for resolution through
administrative review. After reviewing the petition, FDA will decide
whether to grant or deny the petition and will publish a notice of its
decision in the Federal Register. If FDA grants the petition, the
notice will state the issue to be reviewed, the form of review to be
used, the persons who may participate in the review, the time and place
where the review will occur, and other details.
Petitioners may, at any time on or before February 5, 1998, file
with the Dockets Management Branch (address above) two copies of each
petition and supporting data and information, identified with the name
of the device and the docket number found in brackets in the heading of
this document. Received petitions may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
This notice is issued under the Federal Food, Drug, and Cosmetic
Act (secs. 515(d), 520(h) (21 U.S.C. 360e(d), 360j(h))) and under
authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10)
and redelegated to the
[[Page 566]]
Director, Center for Devices and Radiological Health (21 CFR 5.53).
Dated: December 1, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 98-153 Filed 1-5-98; 8:45 am]
BILLING CODE 4160-01-F
