May 6, 2019 — “It doesn’t just take a village, it takes an ecosystem,” Jeffrey Shuren, M.D., J.D., director of the Center for Devices and Radiological Health (CDRH), told the annual meeting of the Reagan-Udall Foundation for the FDA in Washington on May 2, highlighting the challenge of drawing upon a sufficiently broad range of […]
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Feb. 28, 2019 – In a rare promotion-related enforcement action, the FDA’s Center for Devices and Radiological Health (CDRH) issued a Warning Letter to Total Thermal Imaging Inc. (TTI) for claims made about its Thermography Business Package product in the firm’s brochures and on its website. Following an inspection of the firm in summer 2018, […]
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