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United States - Healthcare - Summary Of LDT Rule: An In-Depth Look At The Final Rule Regarding Laboratory-Developed Tests

The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape.

Summary of LDT Rule: An In-depth Look at the Final Rule Regarding Laboratory-Developed Tests | Venable LLP

The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for.

What's in the FDA Final Rule Regulating Laboratory-Developed Tests as Medical Devices? | Alston & Bird

Philips receives warning letter from FDA regarding manufacturing facility

The Agency alleges the company's CT and ultrasonography systems are noncompliant with good manufacturing requirements.

FDA issues warning letter to Philips regarding manufacturing facility

The Agency alleges the company's CT and ultrasonography systems are noncompliant with good manufacturing requirements.