FDA finalizes lab developed test rule over industry opposition.

The Food and Drug Administration (FDA) has released a final rule strengthening its authority over laboratory developed tests (LDTs), despite opposition from healthcare industry groups. The rule states that in vitro diagnostics, including those manufactured by laboratories, are considered devices under the Federal Food, Drug and Cosmetic Act. The FDA plans to phase out its enforcement discretion approach for LDTs, subjecting them to the same enforcement policy as other tests. Critics argue that this increased oversight will slow down the development of cutting-edge diagnostics, while the FDA asserts that it is necessary to ensure accuracy and patient safety. [Extracted from the article]

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