FDA > CDRH > Personal Protective Equipment > FDA's Role in Regulating PPE

FDA's Role in Regulating PPE

On this page:

• About FDA
• FDA's role in PPE
• Finding FDA-cleared PPE
• Roles of other Government agencies

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.

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 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:

• 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.

Finding FDA-cleared PPE

FDA’s website lets you search for medical devices that FDA has cleared or approved, including personal protective equipment.

• Search for all FDA-cleared surgical masks
• Search for all FDA-cleared surgical N95 respirators
• Search for all FDA-cleared medical gloves
• Search for all FDA-cleared surgical gowns

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). 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.

Updated May 9, 2006