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By Staff Reporters
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The Food and Drug Administration wants to make sure that if someone is analyzing your blood and urine, it’s worth your time, so the agency just finalized regulations to govern the $10 billion lab test industry. Tests designed by laboratories have long gone without government scrutiny, but the FDA said the time has come to ensure these tests are accurate—though the new standards will be phased in over several years.
There are currently about 80,000 medical tests available from ~1,200 labs, per the FDA, and those will mostly be grandfathered in. Still, the industry has pushed back, saying the regulations will inhibit innovation, and could sue to block the rules from taking effect.
CITE: https://www.r2library.com/Resource
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Filed under: "Doctors Only", Career Development, Drugs and Pharma, Ethics, Health Economics, Health Insurance, Health Law & Policy, Healthcare Finance | Tagged: FDA, FDA regulation laboratory tests, Food Drug Administration, lab tests, laboratory tests |
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