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Food and Drug Administration FDA published a Warning Letter to RightEye, LLC RightEye manufacturer of RightEye Vision System, for misbranding and adulteration. RightEye Vision System is a Class II Nystagmograph medical device which is cleared under its 510k.
On January 31, 2023, the U.S. Food and Drug Administration (FDA) published a Warning Letter to RightEye, LLC (RightEye), the manufacturer of the RightEye Vision System, for misbranding...
The Obama Administration is aggressively exploiting regulation to achieve its policy agenda, issuing 157 new major rules at a cost to Americans approaching $73 billion annually.
With a September 24, 2022 compliance date looming, the U.S. Food and Drug Administration (FDA) announced that it will delay enforcement of its requirement to submit Unique Device...
Serialization 101 Fraud is a serious issue for drug manufacturing, and pharmaceutical and medical device regulations using serialization have been mandated to defend against counterfeiting. Jan 13th, 2021 In the realm of pharmaceuticals, there are some concerning statistics according to the Pharmaceutical Research and Manufacturers of America. One in ten medicines worldwide are presumed to be counterfeit, and 95% of internet drug outlets have been found to be out of compliance with federal and state pharmacy laws & practice standards. During one week alone in March of 2020, over 48,000 packag...