[Federal Register Volume 62, Number 62 (Tuesday, April 1, 1997)]
[Notices]
[Page 15528]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-8170]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 97M-0122]
Xillix Technologies Corp.; Premarket Approval of Xillix LIFE-Lung
Fluoresence Endoscopy 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 submitted by Hogan and Hartson, Washington,
DC, U.S. representative for Xillix Technologies Corp., Richmond, B.C.,
Canada, for premarket approval, under the Federal Food, Drug, and
Cosmetic Act (the act), of Xillix LIFE-Lung Fluoresence Endoscopy
System. After reviewing the recommendation of the Ear, Nose, and Throat
Devices Panel, FDA's Center for Devices and Radiological Health (CDRH)
notified the applicant, by letter of September 19, 1996, of the
approval of the application.
DATES: Petitions for administrative review by May 1, 1997.
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: Kirby J. Cooper, Center for Devices
and Radiological Health (HFZ-470), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2080.
SUPPLEMENTARY INFORMATION: On December 21, 1995, Hogan and Hartson,
Washington, DC, U.S. representative for Xillix Technologies Corp.,
Richmond, B.C. Canada, submitted to CDRH an application for premarket
approval of Xillix LIFE-Lung Fluorescence Endoscopy System. The device
is a fluorescence endoscopy system and is indicated for use as an
adjunct to white light bronchoscopy, using an Olympus BF-20D
bronchoscope, to enhance the physician's ability to identify and locate
bronchial tissue, suspicious for moderate/severe dysplasia or worse,
for biopsy and histologic evaluation in the following patient
populations:
1. Patients with known or previously diagnosed lung cancer; and
2. Patients with suspected lung cancer including: (a) Patients with
Stage I completely resected lung cancer, with no evidence of metastatic
disease, who are at risk for secondary disease; and (b) patients
suspected of having lung cancer because of clinical symptoms such as
positive sputum cytology, hemoptysis, unresolved pneumonia, persistent
cough, or positive x-ray.
On June 11, 1996, the Ear, Nose, and Throat Devices Panel of the
Medical Devices Advisory Committee, an FDA advisory committee, reviewed
and recommended approval of the application. On September 19, 1996,
CDRH approved the application by a letter to the applicant from the
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, 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 May 1, 1997, 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 Director, Center for Devices and Radiological
Health (21 CFR 5.53).
Dated: March 4, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health
[FR Doc. 97-8170 Filed 3-31-97; 8:45 am]
BILLING CODE 4160-01-F