[Federal Register: April 21, 2003 (Volume 68, Number 76)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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Medical Devices: Draft Guidance for Industry and FDA Reviewers;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
AGENCY: Food and Drug Administration, HHS.
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availability of the draft guidance for industry entitled ``Multiplex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 This draft guidance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 This draft guidance document is neither final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DATES: Submit written or electronic comments on this draft guidance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diskette of the draft guidance entitled ``Multiplex Tests for Heritable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
Submit written comments on this draft guidance to the Dockets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-
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
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)).
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]
BILLING CODE 4160-01-S