[Federal Register Volume 75, Number 116 (Thursday, June 17, 2010)]
[Notices]
[Pages 34463-34464]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-14654]
[[Page 34463]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0274]
Oversight of Laboratory Developed Tests; Public Meeting; Request
for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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Summary: The Food and Drug Administration (FDA) is announcing the
following public meeting: ``Oversight of Laboratory Developed Tests.''
The purpose of the public meeting is to create a forum for interested
stakeholders to discuss the agency's oversight of laboratory developed
tests (LDTs). FDA is seeking input and requesting comments on this
topic.
Date and Time: The public meeting will be held on July 19 and 20,
2010, from 8 a.m. to 5 p.m.
Location: The public meeting will be held at Crowne Plaza
Washington, DC - Rockville, 3 Research Court, Rockville, MD 20850. For
directions, please contact the hotel 301-840-0200 or refer to the
meeting web page at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
Contact: Katherine Serrano, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, rm. 5613, Silver Spring MD 20993-0002, 301-796-6652, e-mail:
[email protected].
Registration and Requests for Oral Presentations: There is no
registration fee to attend the public meeting. Registration can be
completed online at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. Online registration is available
until 5 p.m. on July 12, 2010. Persons without Internet access may call
Katherine Serrano at 301-796-6652 by July 12, 2010, to register for the
meeting. Early registration is recommended because seating is limited.
If space permits, onsite registration will be permitted on a first-
come, first-served basis.
Interested persons who would like to make a presentation during the
meeting will be given 10 minutes to do so if they submit their request
(either electronic or written) to the contact person at the address
shown in the Contact section of this document, and to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852 (including name, title,
firm name, address, telephone, and fax number). All requests should
indicate in which of the four sessions of the meeting the person would
like to present. Persons who would like to present in multiple sessions
should indicate this in their request as well as provide a
prioritization of the sessions in which they would like to present. A
copy of the material to be presented may also be submitted with
requests. Depending upon the number of individuals and organizations
that submit requests to present, the allotted time may be expanded or
shortened to provide all interested parties an opportunity to present.
Requests to present are to be identified with the docket number found
in brackets in the heading of this document.
If you need special accommodations due to a disability, please
contact Katherine Serrano (see Contact) at least 7 days in advance of
the meeting.
Comments: FDA is holding this public meeting to provide a public
forum in which it will hear presentations and comments from interested
stakeholders regarding reasonable and effective regulation of LDTs. The
comment period for this public meeting closes on August 15, 2010.
Regardless of attendance at the public meeting, interested persons
may submit either electronic or written comments regarding this
document. Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville MD 20852. It is only necessary to send one set of comments.
It is no longer necessary to send two copies of mailed comments.
Identify comments with the docket number found in brackets in the
heading of this document. Received comments may be seen in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
SUPPLEMENTARY INFORMATION:
I. Background
Since the implementation of the Medical Device Amendments of 1976,
FDA has generally exercised enforcement discretion and not enforced
applicable regulations with respect to LDTs, a class of in vitro
diagnostics that are manufactured, including being developed and
validated, and offered, within a single laboratory. Thus, FDA has not
actively regulated most LDTs.
Initially, laboratories manufactured LDTs that were generally
relatively simple, well-understood pathology tests or that diagnosed
rare diseases and conditions that were intended to be used by
physicians and pathologists within a single institution in which both
were actively part of patient care. These tests were ordinarily either
well-characterized, low-risk diagnostics or for rare diseases for which
adequate validation would not be feasible and the tests were being used
to serve the needs of the local patient population. In addition, the
components of traditional LDTs were regulated individually by FDA as
analyte specific reagents or other specific or general reagents, and
the tests were developed and offered in laboratories with certificates
to perform high complexity tests under the Clinical Laboratory
Improvement Amendments of 1988, which are laboratories that have
extensive experience in complex laboratory testing. Today, while these
tests are still performed in laboratories with high complexity
certificates, they often use components that are not regulated
individually by FDA, and they are often used to assess high-risk but
relatively common diseases and conditions and to inform critical
treatment decisions and are often performed in geographically distant
commercial laboratories instead of within the patient's health care
setting under the supervision of a patient's pathologist and treating
physician, or may be marketed directly to consumers. In addition, even
when FDA-approved tests are available for a disease or condition,
laboratories often continue to use LDTs that have not been reviewed by
the agency. Finally, an increasing number of LDT manufacturers are
corporations rather than hospitals or public health laboratories, which
represent a significant shift in the types of tests developed and the
business model for developing them.
At the same time as LDTs are becoming more complex, diagnostic
tests are playing an increasingly important role in clinical
decisionmaking and disease management, particularly in the context of
personalized medicine. However, LDTs that have not been properly
validated for their intended use put patients at risk. Risks include
missed diagnosis, wrong diagnosis, and failure to receive appropriate
treatment. In April of 2008, the Secretary's Advisory Committee on
Genetics, Health, and Society, in its report entitled ``U.S. System of
Oversight of Genetic Testing,'' recommended that ``FDA should address
all laboratory tests in a manner that takes advantage of its current
experience in evaluating laboratory tests.''
FDA also recognizes that while the absence of FDA oversight may
make it
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easier for laboratories to develop and offer tests on a rapid timeline,
the absence of a level playing field creates a competitive disadvantage
and potential disincentive to innovation by other manufacturers whose
tests are approved or cleared by the agency for similar indications. In
addition, as set out above, it means that some diagnostics critical for
patient care may not be developed in a manner that provides a
reasonable assurance of safety and effectiveness.
In response to these public health concerns, the agency believes it
is time to reconsider its policy of enforcement discretion over LDTs.
The public must be assured that the tests used in the provision of
health care, whether developed by a laboratory or other manufacturer,
are safe and effective. However, The FDA recognizes that there are
issues unique to the laboratory community that should be taken into
consideration so that patients will receive the desired benefits of
innovative, yet safe and effective, diagnostic tests. FDA recognizes
the importance of implementing an oversight framework that fosters
innovation in this area while assuring that such tests are safe and
effective. For example, the field of genomics and genetic testing has
the potential to revolutionize patient care. As a second example,
fostering innovation in tests for rare diseases and conditions is
another important public health concern. In these and other categories,
it is important that FDA provide a reasonable, predictable, and
consistent regulatory policy for ensuring the safety and effectiveness
of LDTs and provide sufficient time for implementation. Therefore, this
policy should encourage innovation, improve patient outcomes,
strengthen patient confidence in the reliability of these products, and
help reduce health care costs.
At this time, FDA believes that a risk-based application of
oversight to LDTs is the appropriate approach to achieve the desired
public health goals and would like to hear from stakeholders, including
laboratory professionals, clinicians, patients, and industry, as we
develop our draft oversight framework, to define the issues that pose
the greatest concern to the public health. The public meeting announced
in this notice will serve as a forum to discuss issues and stakeholder
concerns surrounding LDT oversight. Following the public meeting and
the close of the public docket the FDA will move forward expeditiously
to develop a draft oversight framework for public comment to provide
predictability as quickly as possible. The FDA also intends to phase in
such a framework over time based on the level of risk of the test.
II. Agenda
FDA will start the public meeting with a series of presentations
introducing the history and current regulatory status of LDTs. The
remainder of the meeting will be divided into four sessions
highlighting areas in which FDA hopes to gain public input from
critical perspectives in response to its proposal to develop an
oversight framework, as well as to hear stakeholder opinions on which
issues around laboratory developed testing present the greatest concern
to the public health. These sessions include the following: (1) Patient
Considerations, (2) Challenges for Laboratories, (3) Direct to Consumer
Marketing of Testing, and (4) Education and Outreach. Each session will
consist of approximately 2 hours of public presentations focused on the
session topic followed by an expert panel discussion and a question-
and-answer period. This public meeting agenda will be available on the
Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
III. Transcripts
Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov. A link to the
transcripts will also be available on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm
approximately 45 days after the meeting. The transcript may be viewed
at the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information (HFI-35), Office
of Management Programs, Food and Drug Administration, 5600 Fishers
Lane, rm. 6-30, Rockville, MD 20857.
Dated: June 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-14654 Filed 6-16-10; 8:45 am]
BILLING CODE 4160-01-S