{"id":"AGY-FED-HEALTH-OTHER-043","kind":"context","level":"federal","jurisdiction":"United States (federal); Food and Drug Administration, Center for Devices and Radiological Health","state":"","metro":"","industry":"","agency":"FED-HEALTH-OTHER","eco":"","issuer":"Food and Drug Administration, CDRH","authority":"FD\u0026C Act ss. 510(k), 513, 519, 520; 21 C.F.R. parts 807, 820, 868; enforcement discretion","instrument":"Guidance for Industry and FDA Staff: Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (March 2020)","title":"Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency","dateIssued":"2020-03-22","effective":"2020-03-22 (immediately in effect; announced 85 Fed. Reg. 27987)","end":"For the duration of the public health emergency including renewals (transition per 88 Fed. Reg. 15417)","startDate":"2020-03-22","endDate":"2021-09-30","quarters":["2020Q2","2020Q3","2020Q4","2021Q1","2021Q2","2021Q3"],"types":["SUPPLY","HC","OTHER"],"addressees":["manufacturers of ventilators, anesthesia gas machines, CPAP/BiPAP and other respiratory devices; health care facilities"],"clause":"This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the Secretary in accordance with section 319(a)(2) of the PHS Act.... for the duration of the public health emergency, to help foster the wider availability of devices for patients in need of ventilatory support, FDA does not intend to object to modifications to the FDA-cleared indications, claims, or functionality of these devices, without prior submission of a premarket notification","enforcement":"Enforcement discretion under 21 U.S.C. 331 for the premarket-notification, quality-system and labeling requirements listed","functions":["PF production floor (manufacturers modifying and converting lines)","SC supply chain","IP inpatient surge capacity"],"notes":"With the ventilator EUA of Mar. 24, 2020 (Ex. 051), the instrument under which automotive, aerospace and medical-device manufacturers produced and modified ventilators in 2020.","sourceUrl":"https://www.fda.gov/media/136318/download","snapshot":"https://web.archive.org/web/20200324153649/https://www.fda.gov/media/136318/download","fileExists":true,"fileBytes":182570,"grade":"primary","character":"context","description":"","collection":"AGY-FED-HEALTH-OTHER","url":"/library/AGY-FED-HEALTH-OTHER-043","exhibitUrl":"/exhibit/AGY-FED-HEALTH-OTHER-043","citation":"Food and Drug Administration, CDRH, Guidance for Industry and FDA Staff: Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (March 2020) (Mar. 22, 2020) (Ex. AGY-FED-HEALTH-OTHER-043)","stateName":"","related":["AGY-FED-HEALTH-OTHER-044"]}