[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