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Examples of products that CDRH regulates include medical devices ranging from tongue depressors and personal protective equipment (PPE) to pacemakers and robotic surgical systems, and medical and non-medical radiation-emitting electronic products such as lasers, x-ray systems, ultrasound equipment, microwave ovens, and color televisions.
During the COVID-19 pandemic, the mask and respirator market rapidly grew, along with counterfeit respirators. [1] NIOSH, on behalf of the Department of Health and Human Services, filed a trademark application on June 17, 2020, for various 42 CFR 84 trademarks, including the N95, allowing NIOSH to enforce rules on counterfeit masks outside of rules defined in 42 CFR 84.
701 Labeling requirements; The 800 series are for medical devices: 803 Medical device reporting; 814 Premarket approval of medical devices [3] 820 et seq. Quality system regulations (analogous to cGMP, but structured like ISO) [4] 860 et seq. Listing of specific approved devices and how they are classified
40 CFR Part 792, Good Laboratory Practice Standards, covers the broader application of GLP standards for nonclinical laboratory studies conducted for assessing the safety or efficacy of chemical substances, including pesticides, under various regulatory programs overseen by the EPA. This regulation applies to nonclinical laboratory studies ...
The pictogram for harmful substances of the Globally Harmonized System of Classification and Labelling of Chemicals.. The Globally Harmonized System of Classification and Labelling of Chemicals (GHS) is an internationally agreed-upon standard managed by the United Nations that was set up to replace the assortment of hazardous material classification and labelling schemes previously used around ...
Precautionary statements form part of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). [1] They are intended to form a set of standardized phrases giving advice about the correct handling of chemical substances and mixtures, which can be translated into different languages.
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