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1 1 (September 22, 2020)

handle is hein.crs/govdbvm0001 and id is 1 raw text is: FF. ' riE S-' $. h ,i . , Updated September 22, 2020 Personal Protective Equipment (PPE) and COVID-19: FDA Regulation and Related Activities The Coronavirus Disease 2019 (COVID-19) pandemic has affected the medical product supply chain globally and domestically. The impact of COVID-19 on the availability of personal protective equipment (PPE), such as gowns, gloves, respirators, and surgical masks, for health care personnel continues to be a concern. PPE is generally worn by health care personnel to protect the wearer from infection or illness from blood, body fluids, or respiratory secretions. In the United States, PPE intended for use in the cure, mitigation, treatment, or prevention of disease meet the definition of a medical device (device) under the Federal Food, Drug, and Cosmetic Act (FFDCA) and are regulated by the U.S. Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS). PPE that do not meet the FFDCA definition of device (i.e., not intended for medical use) are not regulated by FDA. This In Focus provides an overview of how FDA regulates PPE and summarizes the agency's response to mitigate reported PPE shortages related to COVID-19. In general, any company interested in distributing medical PPE in the United States would need permission from FDA. Pursuant to its authorities in the FFDCA, FDA regulates medical devices based on the risk they pose to consumers. There are three regulatory classes of devices with different applicable requirements: class I (low risk), class II (moderate risk), and class III (high risk). Class II devices are subject to special controls, and class III devices are subject to premarket approval (PMA). However, all devices regardless of regulatory class are subject to general controls (e.g., establishment registration, good manufacturing practices) unless exempt. Premarket notification, which requires a 5 10(k) submission, is a general control that applies to certain class I and most class II devices, and requires manufacturers to submit certain materials to FDA at least 90 days prior to marketing (21 U.S.C. §360(k)). To receive a 5 10(k) clearance, a manufacturer must demonstrate that the device proposed to be marketed is substantially equivalent to a device already on the market. In general, a 510(k) submission includes the regulatory class of the device, actions taken to comply with relevant performance standards, proposed labeling, and a statement describing how the device is similar to or different from a predicate device, among other things (21 C.F.R. §807.87). There are certain circumstances under which a change to an existing device would require a new 5 10(k) submission. According to FDA guidance, such changes include, among other things, labeling, technology, and/or materials used. Regulatory requirements vary by type of PPE, which are generally class I or II devices. Medical gloves are used to protect the wearer from the spread of infection during medical procedures and examinations. Medical gloves are class I devices that require a 5 10(k) clearance, and include patient examination gloves (21 C.F.R. §880.6250) and surgical gloves (21 C.F.R. §878.4460). NdctG ow,-&, Medical gowns (21 C.F.R. §878.4040) are a type of surgical apparel used to protect against infection or illness if contact with infectious liquid or solid material is likely. Manufacturers are encouraged to comply with national consensus standards so their gowns provide any one of four levels of protection: level 1 (minimal risk), level 2 (low risk), level 3 (moderate risk), and level 4 (high risk). While medical gown terminology is not standardized, FDA generally regulates medical gowns in three categories: * Nonsurgical gowns are intended for use in minimal-to- low risk patient isolation situations (level 1-2) and are class I devices exempt from premarket review (i.e., 510(k) notification or PMA approval). * Surgical isolation gowns are used in moderate- to high- risk situations (level 3-4) and are class II devices subject to 5 10(k) notification and certain special controls (e.g., performance standards). * Surgical gowns are generally used during surgical procedures but can be used for any risk level (levels 1-4) and are class II devices subject to 510(k) notification and certain special controls. Masks are a broad category of PPE that include surgical masks and filtering facepiece respirators (FFRs). FFRs intended for medical use (e.g., surgical N95 FFRs) are subject to both National Institute for Occupational Safety and Health (NIOSH) approval and FDA regulation as devices. Surgical masks and surgical N95 FFRs (21 C.F.R. §§878.4040 and 880.6260) both class II medical devices requiring 510(k) notification, unless exempt provide a physical barrier to fluids and particulate matter by covering the nose or mouth. Both are tested for fluid resistance, filtration efficiency, flammability, and biocompatibility. Surgical masks are loose-fitting, while surgical N95 FFRs form a tight seal around the nose and mouth, providing very efficient filtration (i.e., 95%) of airborne particles. p\w -- , gn'a', goo mppm qq\ , q I 'S 11LULANJILiN,

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