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1 1 (April 2, 2020)

handle is hein.crs/govcqyr0001 and id is 1 raw text is: FF.ri E~$~ & April 2, 2020 Personal Protective Equipment and Ventilators for COVID-19: FDA Regulation and Related Activities The Coronavirus Disease 2019 (COVID-19) pandemic has affected the medical product supply chain both globally and domestically. Perhaps most salient has been the impact of COVID-19 on the availability of personal protective equipment (PPE), such as gowns and masks, for health care personnel, and respiratory devices, including ventilators, for patients. In the United States, respiratory devices and PPE used in the health care setting meet the definition of a medical 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). This In Focus provides an overview of how these devices are regulated and summarizes the FDA response to mitigate reported PPE and ventilator shortages related to COVID-19. F-A NY2 4 P anc, Vertx In general, any company interested in distributing medical PPE or ventilators a type of respiratory device-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 medical 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 510(k) submission, is a type of 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 510(k) clearance, the manufacturer must demonstrate that the device proposed to be marketed is substantially equivalent to a device already on the market. Generally, 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. PPE refers to single-use protective gowns, gloves, masks, and respirators intended to block transmission of infection from blood, body fluids, or respiratory secretions. Regulatory requirements vary by type of PPE, which are generally class I or II devices. Medical gloves are used to protect an individual 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). 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 low- or minimal-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 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 5 10(k) notification and special controls. Face masks are a broad category of PPE that include surgical masks and filtering facepiece respirators (FFRs). FFRs and other respirators for occupational use (e.g., N95 FFRs) are subject to certification and approval by the National Institute for Occupational Safety and Health (NIOSH). FFRs intended for nonmedical or general public use are not subject to FDA oversight. FFRs intended for medical use (e.g., surgical N95 FFRs) are subject to both NIOSH approval and FDA regulation as devices. Surgical masks and surgical N95 FFRs (21 C.F.R. §§878.4040 and 878.6260) 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. mppm qq\ ' p\w -- ' gn'a', g-o I 'S 11LULANJILiN,

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