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FDA Gathers Feedback To Guide Oversight Of Lab-Developed Testing

This article was originally published in The Gray Sheet

Executive Summary

FDA says it will tailor its future oversight of laboratory tests and services based on risk, but experts warn that "high risk" will be hard to define for these diagnostics

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FDA Official Gives Policy Update On Lab-Developed Tests

Most laboratory-developed tests have no predicates, said Elizabeth Mansfield, director of personalized medicine in CDRH’s diagnostics office, hinting that many may require pre-market submissions that go beyond 510(k) review standards once the agency initiates plans for active oversight of the category.

FDA Official Gives Policy Update On Lab-Developed Tests

Most laboratory-developed tests have no predicates, said Elizabeth Mansfield, director of personalized medicine in CDRH’s diagnostics office, hinting that many may require pre-market submissions that go beyond 510(k) review standards once the agency initiates plans for active oversight of the category.

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