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Class II: Devices that are cleared using the 510(k) process. Diagnostic tests, cardiac catheters, hearing aids, and dental amalgams are examples of class II devices. Class III: Devices that are approved by the premarket approval (PMA) process, analogous to a New Drug Application. These tend to be devices that are permanently implanted into a ...
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
The OSH Act covers most private sector employers in all 50 states, the District of Columbia, and other U.S. jurisdictions—either directly through federal OSHA or through an OSHA-approved state plan. State plans are OSHA-approved job safety and health programs operated by individual states instead of federal OSHA.
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies.Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, [1] cosmetics, [2] pharmaceutical products, [3] dietary supplements, [4] and medical devices. [5]
An environmental health officer (EHO), also referred to as an environmental health practitioner (EHP) or public health inspector, is a person responsible for carrying out measures to protect public health, [1] which includes the administration and enforcement of legislation related to environmental health and safety hazards.
CSTDs generally follow one of two design concepts, using either a physical barrier or an air-cleaning technology to prevent the escape of hazardous drugs into the work environment. Physical barrier - Blocking the unintended release of drug into the surrounding environment or the intake of environment contaminates into a sterile drug pathway. [8]
Certification in the medical profession is often offered by particular specialties. In order to apply professional standards, increase the level of practice, and protect the public, a professional organization might establish a certification. This is intended to be portable to all places a certified professional might work.
The FDA can only ban a supplement if the FDA finds proof that the supplement is dangerous. This means that unsafe or ineffective supplements can be sold freely, while the FDA has only a limited capacity to monitor adverse reactions from supplements. [19] [20] David Kessler, commissioner of the FDA when DSHEA was approved, has stated that