FDA Oversight of Laboratory Developed Tests (LDTs): Meeting and Comment Period
The Food and Drug Administration (FDA) is reviewing its policy of enforcement discretion regarding LDTs to assure the public that lab tests are safe and effective. To that end, the FDA is hosting a public meeting on oversight of Laboratory Developed Tests on July 19 and 20, 2010. The agency also will accept comments from stakeholders on "reasonable and effective regulation of LDTs" until August 15, 2010. The FDA "believes that a risk-based application of oversight to LDTs is the appropriate approach to achieve the desired public health goals.” The agency seeks comments from stakeholders on the issues that pose the greatest concern to the public health. After the meeting and public comment period, the "FDA will move forward expeditiously to develop a draft oversight framework for public comment.”
