[Federal Register Volume 75, Number 116 (Thursday, June 17, 2010)]
[Pages 34463-34464]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-14654]

[[Page 34463]]



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.


    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 
    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: 
    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.


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

[[Page 34464]]

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]