|
FDA's Role in Regulating PPEOn this page:About FDAThe Food and Drug Administration (FDA) is the U.S. Government agency that oversees most medical products, foods, and cosmetics. Within FDA, the Center for Devices and Radiological Health (CDRH) oversees the safety and effectiveness of medical devices and radiation-emitting products. FDA's role in PPEPPE that is intended for use in preventing or treating disease is subject to regulation under the device provisions of the Federal Food, Drug, and Cosmetic Act. This includes s urgical masks, surgical N95 respirators, medical gloves, and surgical gowns. Before these devices can be sold in the U.S., FDA evaluates the manufacturer's new product applications (premarket notifications or 510[k]s) to make sure that the new devices are similar to (substantially equivalent to) existing products already on the market. FDA refers to this as clearing the products for market. Once FDA has cleared the products, it:
If FDA finds ongoing problems with a medical product, it may oversee a manufacturer's recall, recommend changes to the labeling or instructions, or suggest corrective actions. For more information on how FDA regulates PPE and other medical devices, see FDA Device Advice: Overview of Regulations.Finding FDA-cleared PPEFDA’s website lets you search for medical devices that FDA has cleared or approved, including personal protective equipment.
Roles of other Government agenciesOSHA (the U.S. Department of Labor's Occupational Safety and Health Administration) requires employers to provide appropriate PPE for workers who could be exposed to blood or other infectious materials (bloodborne pathogens). Although OSHA requires the use of specific equipment, it does not regulate the marketing of these devices nor grant claims of disease prevention.
For more information on OSHA's bloodborne pathogen standard, see Bloodborne pathogens. CDC (the U.S. Centers for Disease Control and Prevention) publishes guidelines and recommendations for infection control, including personal protective equipment. For more information on CDC recommendations, see Infection Control in Healthcare Settings. The National Institute for Occupational Safety and Health (NIOSH) has established certification requirements for various respiratory PPE, which are found at 42 CFR part 84. NIOSH tests products for compliance with these regulations and issues a certification for products that comply. NIOSH certification evaluates the performance of respiratory protection equipment in functional terms and not in terms of claims for use in preventing disease. NIOSH certification is not required for a non-medical respirator to be sold. However, employers subject to OSHA and the Mine Safety and Health Administration (MSHA) regulation may be required to provide NIOSH-certified respiratory protection equipment to satisfy their OSHA and MSHA requirements.Updated May 9, 2006 |
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH