[Federal Register Volume 62, Number 242 (Wednesday, December 17, 1997)]
[Notices]
[Pages 66112-66113]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32875]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97D-0430]


Medical Devices; Guidance Document for the Submission of Tumor 
Associated Antigen Premarket Notifications, [510(k)], to FDA; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance entitled ``Guidance Document for the 
Submission of Tumor Associated Antigen Premarket Notifications, 
[510(k)], to FDA.'' The guidance document provides suggestions for the 
nonclinical laboratory studies and the design, conduct, and analysis of 
appropriate clinical studies that the Center for Devices and 
Radiological Health (CDRH), FDA, believes will provide reasonable 
assurance of the safety and effectiveness of these devices. The 
guidance document also sets forth the review criteria and describes the 
data to support a 510(k) submission. The guidance accompanies a final 
rule, which appears elsewhere in this issue of the Federal Register, 
announcing the reclassification of tumor associated antigen 
immunological test systems from class III (premarket approval) to class 
II (special controls).

DATES: Written comments may be submitted at any time.

ADDRESSES: Submit written comments concerning this guidance document to 
the contact person listed below. Submit written requests for single 
copies of ``Guidance Document for the Submission of Tumor Associated 
Antigen Premarket Notifications, [510(k)], to FDA'' to the Division of 
Small Manufacturers Assistance (DSMA), Center for Devices and 
Radiological Health (HFZ-220), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive 
labels to assist the office in processing your request, or fax your 
request to 301-443-8818. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Peter E. Maxim, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-1293.

SUPPLEMENTARY INFORMATION:

I. Background

     FDA issued an order (September 19, 1996) in the form of a letter 
reclassifying tumor associated antigen immunological test systems from 
class III to class II. The order identified the premarket notification 
guidance document for tumor associated antigens as one of the 
designated special controls. The guidance document contains general 
information on the definition of qualifying devices and the 
administrative requirements for submitting a 510(k) to FDA. The 
document also lists the types of nonclinical (analytical) studies to be 
included in the submission. These studies include reagent 
characterization, assay specificity, and device performance 
characteristics to include precision, linearity, interfering 
substances, analytical sensitivity and methods of comparison to another 
device. Finally, the document provides guidance on the design of 
clinical studies to support a submission for a new tumor marker 
intended to monitor previously treated patients.
     This guidance document represents the agency's current thinking on 
the design of clinical studies expected to support a 510(k) submission 
for new tumor markers intended to monitor previously treated patients. 
It does not create or confer any rights for or on any person and does 
not operate to bind FDA or the public. An alternative approach may be 
used if such approach satisfies the requirements of the applicable 
statute, regulation, or both.

II. Requests for Comments

    Interested persons may, at any time, submit to the contact person 
listed above written comments regarding this guidance document. Two 
copies of any comments are to be submitted, except that individuals may 
submit one copy. Comments are to be identified with the docket number 
found in brackets in the heading of this document.

III. Electronic Access

     In order to receive the ``Guidance Document for the Submission of 
Tumor Associated Antigen Premarket Notifications, [510(k)], to FDA'' 
via your fax machine, call the CDRH Facts-On-Demand system at 1-800-
899-0381 or 301-827-0111 from a touch-tone telephone. At the first 
voice prompt press 1 to access DSMA Facts, at second voice prompt press 
2, and then enter the document number (957) followed by the pound sign 
(#). Follow the remaining voice prompts to complete your request.
     Persons interested in obtaining a copy of the guidance may also do 
so using the World Wide Web (WWW). The CDRH maintains an entry on the 
WWW for easy access to the Web. Updated on a regular basis, the CDRH 
home page includes ``Guidance Document for the Submission of Tumor 
Associated Antigen Premarket Notifications, [510(k)], to FDA,'' device 
safety alerts, Federal Register reprints, information on premarket 
submissions (including lists of approved applications and 
manufacturers' addresses), small manufacturers' assistance, information 
on video conferencing and electronic submissions, mammography matters, 
and other device-oriented information. The CDRH home page may be 
accessed at http://www.fda.gov/cdrh. ``Guidance Document for the 
Submission of Tumor Associated Antigen Premarket Notifications, 
[510(k)], to FDA'' will be available at http://www.fda.gov/cdrh/ode/
ed_cl.html.
    A text-only version of the CDRH Web site is also available from a 
computer or VT-100 compatible terminal by dialing 1-800-222-0185 
(terminal settings are 8/1/N). Once the modem answers, press Enter 
several times and select menu choice 1: FDA BULLETIN BOARD SERVICE. 
From there follow instructions for logging in, and at the BBS TOPICS 
PAGE, arrow down to the FDA home page (do not select the first CDRH 
entry). Then select Medical Devices and Radiological Health. From there 
select CENTER FOR DEVICES

[[Page 66113]]

AND RADIOLOGICAL HEALTH for general information, or arrow down for 
specific topics.

    Dated: October 7, 1997.
 Joseph A. Levitt,
 Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-32875 Filed 12-16-97; 8:45 am]
BILLING CODE 4160-01-F