WASHINGTON (NEWSnet/AP) — Developers of medical tests will be subject to government oversight to ensure accuracy, according to regulation finalized Monday by U.S. Food and Drug Administration.

FDA bill begin phase-in of oversight of new tests created by laboratories.

The goal is to ensure new tests for cancer, heart disease, COVID-19, genetic conditions and other illnesses are safe, accurate and reliable.

FDA commissioner Robert Califf said inaccurate testing can lead to unnecessary treatment or delay in receiving proper care.T

tests currently on the market will not have to undergo federal review, under a grandfather clause.

Newly developed tests that pose high risk, such as those for life-threatening diseases, will require FDA approval within 3-1/2 years. Lower-risk tests will have four years to obtain approval.

All lab tests, existing or new, will be required to register with the agency and report problems or errors. Based on that information, FDA officials will be able to target problematic tests.

The agency also won’t require approval of tests for which there is no alternative, such as those for certain rare diseases.

FDA already reviews tests and kits made by medical device manufacturers. But labs, large hospitals and universities that develop in-house tests have been able to market them without undergoing agency review. The industry has resisted additional scrutiny, saying it will stifle innovation and increase expense.

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