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General Controls for Medical Devices | FDA
- https://www.fda.gov/medical-devices/regulatory-controls/general-controls-medical-devices
- Medical devices are subject to the adulteration provisions of the FD&C Act under Section 501. The first two provisions of Section 501 define adulteration for most cases. A device is held to be adulterated if it includes any filthy, putrid, or decomposed substance, or if it is prepared, packed, or held … See more
FDA Issues Warning Letter to RightEye, LLC For …
- https://www.natlawreview.com/article/fda-issues-warning-letter-to-righteye-llc-misbranding-and-adulteration
- FDA stated that the RightEye Vision System was misbranded under the Federal, Food, Drug and Cosmetic Act (FDCA) because RightEye introduced the device …
FDA Issues Warning Letter To RightEye, LLC For …
- https://www.mondaq.com/unitedstates/life-sciences-biotechnology--nanotechnology/1282858/fda-issues-warning-letter-to-righteye-llc-for-misbranding-and-adulteration-
- FDA stated that the RightEye Vision System was misbranded under the Federal, Food, Drug and Cosmetic Act (FDCA) because RightEye introduced the device …
FDA Issues Warning Letter to RightEye, LLC For Misbranding …
- https://www.fdalawblog.com/2023/02/articles/fda/fda-issues-warning-letter-to-righteye-llc-for-misbranding-and-adulteration/
- FDA stated that the RightEye Vision System was misbranded under the Federal, Food, Drug and Cosmetic Act (FDCA) because RightEye introduced the device …
Labeling Requirements - Misbranding | FDA
- https://www.fda.gov/medical-devices/general-device-labeling-requirements/labeling-requirements-misbranding
- Misbranding Section 502 of the Federal Food, Drug and Cosmetic Act (FFDCA) contains provisions on misbranding including some that relate to false or misleading labeling. A …
Misbranded & Adulterated Medical Devices - FDA …
- https://blog.clevercompliance.io/medical-product-compliance/misbranded-adulterated-medical-devices/
- An adulterated medical device is any product that has been corrupted or debased by incorporating an impure or spurious substance. The FDCA has …
RightEye receives FDA warning that its product is a medical device
- https://www.massdevice.com/righteye-fda-warning-medical-device/
- An FDA inspection claims that eye-tracking biomarker developer RightEye misbranded and adulterated its medical device. The agency wrote in a letter, dated …
FDA Issues Warning Letter to RightEye, LLC For …
- https://www.martindale.com/legal-news/article_sheppard-mullin-richter-hampton-llp_2559766.htm
- FDA stated that the RightEye Vision System was misbranded under the Federal, Food, Drug and Cosmetic Act (FDCA) because RightEye introduced the device …
FDA Issues Warning Letter to RightEye, LLC For Misbranding …
- https://www.lexology.com/library/detail.aspx?g=f981401f-8095-4290-92f7-c3abf8be6890
- USA February 13 2023. On January 31, 2023, the U.S. Food and Drug Administration (FDA) published a Warning Letter [1] to RightEye, LLC (RightEye), the …
21 U.S. Code § 351 - Adulterated drugs and devices
- https://www.law.cornell.edu/uscode/text/21/351
- A drug or device shall be deemed to be adulterated—. (a) Poisonous, insanitary, etc., ingredients; adequate controls in manufacture. (1) If it consists in whole or in part of any …
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