[Federal Register Volume 62, Number 103 (Thursday, May 29, 1997)]
[Notices]
[Page 29144]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13958]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97M-0204]
QLT Phototherapeutics, Inc.; Premarket Approval of
OPTIGUIDETM Fiber Optic Diffuser (Models DCYL 10, DCYL 15,
and DCYL 25), Coherent Lambda PlusTM PDL1 and PDL2
Photodynamic Lasers, and 600 Series Dye Modules (Models 630 and 630 XP)
and Series 700 and 800 KTP/532 and KTP/YAGTM
Surgical Lasers
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 applications by QLT Phototherapeutics, Inc., submitted
by Hogan & Hartson, Washington, DC on behalf of QLT Phototherapeutics,
Inc., Vancouver, Canada, for premarket approval, under the Federal
Food, Drug, and Cosmetic Act (the act), of the following devices which
constitute the device portion of a combination drug/device product:
OPTIGUIDETM Fiber Optic Diffuser DCYL Series (Models DCYL
10, DCYL 15, and DCYL 25); Coherent Lambda PlusTM PDL1 and
PDL2 Photodynamic Lasers; and 600 Series Dye Modules (Models 630 and
630 XP) and Series 700 and 800 KTP/532 and KTP/
YAGTM Surgical Lasers. These devices are to be used with the
drug PHOTOFRIN under conditions specified in the drug
labeling. After reviewing the recommendation of the Oncologic Drugs
Advisory Committee operating under the authority of the Inter Agency
Agreement regarding combination drug/device products, FDA's Center for
Devices and Radiological Health (CDRH) notified the applicant, by
letter of December 27, 1995, of the approval of the applications.
DATES: Petitions for administrative review by June 30, 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: Richard P. Felten, Center for Devices
and Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1307.
SUPPLEMENTARY INFORMATION: On April 13, 1994, Hogan & Hartson,
Washington, DC 20004-1109, submitted to CDRH, on behalf of QLT
Phototherapeutics, Inc., Vancouver, Canada, applications for premarket
approval of a combination drug/device product which included the
following devices for use with the drug PHOTOFRIN: (1)
OPTIGUIDETM Fiber Optic Diffuser DCYL Series; (2) Coherent
Lambda PlusTM PDL1 and PDL2 Photodynamic Lasers; and (3) 600
Series Dye Modules (Models 630 and 630 XP) and Series 700 and 800 KTP/
532 and KTP/YAGTM Surgical Lasers.
The Fiber Optic Diffuser is indicated as a delivery system for use
in Photodynamic Therapy with PHOTOFRIN for palliation of
patients with completely obstructing esophageal cancer, or of patients
with partially obstructing esophageal cancer who, in the opinion of
their physician, cannot be satisfactorily treated with Nd:YAG laser
therapy. The laser systems are indicated for use in Photodynamic
Therapy as sources for the photoactivation of PHOTOFRIN for
palliation of patients with completely obstructing esophageal cancer,
or of patients with partially obstructing esophageal cancer who, in the
opinion of their physician, cannot be satisfactorily treated with
Nd:YAG laser therapy.
On September 21, 1995, the Immunology Devices Panel of the Medical
Devices Advisory Committee, an FDA advisory committee, operating under
the authority of the Inter Agency Agreement for combination drug/device
products, reviewed and recommended approval of the applications. On
December 27, 1995, CDRH approved the applications by a letter to the
applicant from the Director of the Office of Device Evaluation, CDRH.
Summaries of the safety and effectiveness data on which CDRH based
its approval are on file in the Dockets Management Branch (address
above) and are 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 these applications.
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 the 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 June 30, 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 devices 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: April 18, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 97-13958 Filed 5-28-97; 8:45 am]
BILLING CODE 4160-01-F