FDA seeks public input on regulation of laboratory-developed tests

U.S. Food and Drug AdministrationJun 17 2010

Agency seeking public input on reasonable and effective regulation to protect public health

The U.S. Food and Drug Administration today announced plans to hold a public meeting on July 19-20, 2010, to discuss how the agency will oversee laboratory-developed tests (LDTs).

LDTs refer to in vitro diagnostics that are manufactured by and offered in the same laboratory. They include some genetic tests, and tests that may lead patients to make important medical decisions.

Since the implementation of the 1976 Medical Device Amendments, the FDA has generally exercised its enforcement discretion and not enforced regulations that apply to LDTs. Initially, the FDA viewed LDTs as relatively simple, well-understood tests that diagnosed rare diseases and conditions, and that were intended to be used by physicians and pathologists in a single institution where they were actively involved in patient care. The tests were ordinarily well-characterized, low risk diagnostic tools.

Over the last 15 years, the nature of LDTs has changed dramatically. Today, these tests are often used to assess high-risk, but relatively common diseases and conditions, and many are genetic tests. These tests are often performed in commercial laboratory settings that are geographically separate from the patient's primary health care professionals and their health care setting.

These tests, which are becoming more complex and high risk, are playing an increasingly important role in clinical decision-making. As a result, LDTs that have not been properly validated put patients at risk, such as for missed diagnosis, wrong diagnosis, and failure to receive appropriate treatment. Therefore, FDA believes that a risk-based application of oversight for LDTs is appropriate, and seeks public input on issues and concerns related to LDT oversight.

During the two-day meeting, an overview of the history and current regulatory status of LDTs will be discussed. The meeting will also be divided into four sessions:

1. Patient Considerations
2. Challenges for Laboratories
3. Direct-to-Consumer Marketing of Testing
4. Education and Outreach.

Each session will consist of public presentations focused on each area and will be followed by an expert panel discussion and question-and-answer period.    

Specific details about the meeting will be published in the Federal Register consistent with applicable law and regulations.

The FDA will collect and review all comments and information presented at the public meeting. Subsequently, the agency will move forward in developing a draft oversight framework for public comment with the goal of providing a level of 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.  

For more information

Public notice - details about the meeting

http://www.federalregister.gov/OFRUpload/OFRData/2010-14654_PI.pdf  

Laboratory Developed Tests

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/LabTest/default.htm