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Personal Protective Equipment for Infection Control | FDA All personal protective equipment (PPE) that is intended for use as a medical device must follow The FDA's regulations and should meet applicable voluntary consensus standards for protection.

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Surgical Masks - Premarket Notification [510(k)] … This guidance supersedes “Draft Guidance for Industry and FDA Reviewers on the Content and Format of Premarket Notification [510(k)] Submissions for Surgical Mask” issued January 16, 1998.

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FDA 101: Dietary Supplements | FDA The law defines dietary supplements in part as products taken by mouth that contain a "dietary ingredient." Dietary ingredients include vitamins, minerals, amino acids, and herbs or botanicals, as ...

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Medical Devices | FDA Medical Devices and the COVID-19 (Coronavirus) Pandemic Learn more about devices such as diagnostic tests, ventilators, and personal protective equipment (PPE)—including surgical masks, face ...

Foreign Object Detection: Integration in Food Production - … FDA Health Hazard Evaluation Board conclusions in cases of foreign materials (1972–1997) found that 56 percent of objects 1–6 mm in size might pose a limited acute hazard. For objects greater than 6 mm, only 2.9 percent were judged to present no hazard.

Therapeutic Goods Administration (TGA) | Australian … Australian Government Department of Health The supply and advertising of COVID-19 tests for home use (self-tests) is prohibited in Australia under therapeutic goods legislation.

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