Officials said laboratory developed tests refer to in vitro diagnostics that are manufactured by and offered in the same laboratory, including some genetic tests.
The FDA said previously it has viewed such tests as relatively simple tests intended to be used by physicians and pathologists in a single institution where they were actively involved in patient care.
But during the last 15 years, the nature of LDTs has changed "dramatically," the FDA said. The tests are often used to assess high-risk, but relatively common diseases and conditions, and are often performed in commercial laboratory settings that are geographically separate from the patient's primary healthcare professionals and their health care setting.
"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," the agency said in a statement. "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," the federal agency said.
During the two-day meeting, set for July 19-20 at the Crown Plaza Hotel in Rockville, Md., an overview of the history and current regulatory status of LDTs will be discussed during four separate sessions.
More information is available at http://www.federalregister.gov/OFRUpload/OFRData/2010-14654_PI.pdf.
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