[Federal Register Volume 59, Number 75 (Tuesday, April 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9353]
[[Page Unknown]]
[Federal Register: April 19, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94M-0067]
MBf USA, Inc.; Premarket Approval of AWARE Test System
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 by MBf USA, Inc., Boca Raton, FL, for
premarket approval, under section 515 of the Federal Food, Drug, and
Cosmetic Act (the act), of the AWARE Test System. The Clinical
Chemistry and Toxicology Devices Panel recommendation of approval, with
conditions, was made at a November 4, 1991, panel meeting. Approval was
originally sought for over-the-counter (OTC) use by the applicant.
However, FDA has decided that this panel meeting did not consider
various issues, and so the panel will resume deliberating OTC use at a
second meeting. As a result of the need for a second panel meeting, the
applicant revised the indications for use to reflect a more limited
use. After reviewing the recommendation of the Clinical Chemistry and
Toxicology Devices Panel, FDA's Center for Devices and Radiological
Health (CDRH) notified the applicant, by letter of January 18, 1994, of
the approval of the application.
DATES: Petitions for administrative review by May 19, 1994.
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, rm.
1-23, 12420 Parklawn Dr., Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Kaiser J. Aziz, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 1390
Piccard Dr., Rockville, MD 20850, 301-594-1243.
SUPPLEMENTARY INFORMATION: On December 13, 1990, American Drug Screens,
Inc., Oklahoma City, OK 73108, submitted to CDRH an application for
premarket approval of the AWARE Test System. The device system has
since been sold to MBf USA, Inc., 5100 Town Center Circle, suite 440,
Boca Raton, FL 33486. This device is indicated for use as a specimen
collection container and mailing kit and for drug analysis to determine
if significant levels of marijuana, cocaine, amphetamines,
phencyclidine (PCP), and/or codeine or morphine are present in a urine
sample. It is restricted to use by physicians or professionals who
counsel or treat individuals in connection with drug abuse. This system
is not indicated for employee drug abuse testing, and it is not
available with chain of custody. It is for in vitro diagnostic use
only, and it is not for sale or distribution to pharmacies.
On November 4, 1991, the Clinical Chemistry and Toxicology Devices
Panel of the Medical Devices Advisory Committee, an FDA advisory
committee, reviewed and recommended approval, with conditions, of the
application. On January 18, 1994, CDRH approved the application by a
letter to the applicant from the Acting Director of 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 (21 U.S.C. 360e(d)(3)) authorizes any
interested person to petition, under section 515(g) of the act (21
U.S.C. 360e(g)), for administrative review of CDRH's decision to
approve this application. A petitioner may request either a formal
hearing under part 12 (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
Sec. 10.33(b) (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 May 19, 1994, 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 Center for Devices and Radiological Health (21
CFR 5.53).
Dated: April 5, 1994.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 94-9353 Filed 4-18-94; 8:45 am]
BILLING CODE 4160-01-F