[Federal Register: April 21, 2003 (Volume 68, Number 76)]
[Page 19549-19550]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 03D-0120]

Medical Devices: Draft Guidance for Industry and FDA Reviewers; 
Multiplex Tests for Heritable DNA Markers, Mutations, and Expression 
Patterns; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance for industry entitled ``Multiplex 
Tests for Heritable DNA Markers, Mutations, and Expression Patterns.'' 
FDA has received many inquiries pertaining to multiplex test 
submissions (including microarray submissions). This draft guidance 
document represents the Center for Devices and Radiological Health's 
(CDRH) attempt to continue the dialogue with stakeholders regarding the 
basic framework for the types of data that should be included in a 
submission. FDA is anxious to provide the best guidance possible to 
assist sponsors in developing multiplex text submissions that will 
support timely review and marketing of safe and effective products 
using this technology. This draft guidance document is neither final 
nor is it in effect at this time.

DATES: Submit written or electronic comments on this draft guidance 
document by July 21, 2003.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the draft guidance entitled ``Multiplex Tests for Heritable 
DNA Markers, Mutations, and Expression Patterns'' to the Division of 
Small Manufacturers, International, and Consumer Assistance (HFZ-220), 
Center for Devices and Radiological Health, Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-
addressed adhesive labels to assist that office in processing your 
request or fax your request to 301-443-8818. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the draft 
guidance document.
    Submit written comments on this draft guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to 
http://www.fda.gov/dockets/ecomments. Identify comments with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Mansfield or Michele 
Schoonmaker, Center for Devices and Radiological Health (HFZ-440), Food 
and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-


I. Background

    FDA anticipates that multiplex tests, including such as 
microarrays, using DNA and ribonuclei acid samples will are anticipated 
to have a number of clinical purposes, including genotyping, haplotype 
analysis, and categorization by expression profile, etc. FDA has 
received many inquiries pertaining to possible regulatory strategies 
for submitting and reviewing data from assays yielding multiple, 
simultaneous results. Over the past 24 months, FDA has participated in 
a number of seminars and workshops with representatives from the drug 

[[Page 19550]]

device industries, professional societies, laboratory professionals, 
healthcare providers, and other stakeholders, which discussed the 
criteria that are important in the analytical and clinical validation 
of multiplex assays. These discussions also explore the kind of 
information the industry might submit to the agency to achieve the 
least burdensome means of demonstrating substantial equivalence or 
evaluating effectiveness. FDA is issuing the draft guidance document in 
an effort to continue this dialogue. FDA believes the draft guidance 
document represents a summary of the discussions that have taken place.
    FDA recognizes, however, that the discussions to this point have 
been introductory. Therefore, following review of the comments we 
receive on this draft guidance document, FDA intends to issue a new 
draft guidance document for additional discussion. FDA is taking this 
approach because we believe the public health will benefit from 
dialogue with the industry about appropriate ways to review this new 
and important technology.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on ``Multiplex 
Tests for Heritable DNA Markers, Mutations, and Expression Patterns.'' 
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 the approach satisfies the requirements of the applicable 
statutes and regulations.

III. Paperwork Reduction Act of 1995

    This draft guidance document contains information collection 
provisions that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA). The 
collections of information addressed in the draft guidance document 
have been approved by OMB in accordance with the PRA under the 
regulations governing premarket notification submissions (21 CFR part 
807, subpart E, OMB Control Number 0910-0120 and/or premarket approval 
applications (21 CFR part 814, OMB Control Number 0910-0231)).

IV. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments on the draft guidance. Submit 
a single copy of electronic comments to http://www.fda.gov/dockets/ecomments.
 Submit two hard copies of any mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. The draft guidance and received comments are available 
for public examination in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.

V. Electronic Access

    The CDRH Web site may be accessed at http://www.fda.gov/cdrh. A 
search capability for all CDRH guidance documents is available at 
http://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available on the Dockets Management Branch Internet site at http://www.fda.gov/ohrms/dockets
    To receive a copy of ``Multiplex Tests for Heritable DNA Markers, 
Mutations, and Expression Patterns'' by fax, call the CDRH Facts-On-
Demand system at 800-899-0381 or 301-827-0111 from a touch-tone 
telephone. Press 1 to enter the system. At the second voice prompt, 
press 1 to order a document. Enter the document number (1210) followed 
by the pound sign (). Follow the remaining voice prompts to 
complete your request.
    Persons interested in obtaining a copy of the draft guidance 
document may also do so by using the Internet. CDRH maintains a site on 
the Internet for easy access to information including text, graphics, 
and files that may be downloaded to a personal computer with Internet 
access. Updated on a regular basis, the CDRH home page includes 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.

    Dated: April 3, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-9661 Filed 4-18-03; 8:45 am]