Medical Devices

FDA's Role in Regulating PPE

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About FDA

The 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.

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FDA's role in PPE

PPE 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 surgical masks, 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:

  • maintains databases of those products and their manufacturers;
  • ensures that manufacturers use reliable methods for manufacturing and packaging the products (Good Manufacturing Practices); and
  • reviews and analyzes reports of medical device problems.

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.

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Roles of other Government agencies

OSHA (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). OSHA may also require employers to provide PPE to protect against other hazards at work. Although OSHA requires the use of specific equipment, it does not regulate the marketing of these devices nor grant claims of disease prevention.

29 CFR 1910.1030 Bloodborne pathogens:
When there is occupational exposure, the employer shall provide, at no cost to the employee, appropriate personal protective equipment such as, but not limited to, gloves, gowns, laboratory coats, face shields or masks and eye protection, and mouthpieces, resuscitation bags, pocket masks, or other ventilation devices. Personal protective equipment will be considered "appropriate" only if it does not permit blood or other potentially infectious materials to pass through to or reach the employee's work clothes, street clothes, undergarments, skin, eyes, mouth, or other mucous membranes under normal conditions of use and for the duration of time which the protective equipment will be used.

For more information on OSHA's bloodborne pathogen standard, see Bloodborne pathogens.

CDC (the U.S. Centers for Disease Control and Prevention) gives recommendations for protecting yourself from infection. For updated information on the current flu season, see the CDC Seasonal Flu website.

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.

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Page Last Updated: 06/04/2014
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