COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders | FDA

COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders | FDA

Information for industry

Devices: FDA issued a letter to health care providers to remind reprocessing staff in health care facilities to use the correct sterilization cycle associated with certain models of the Advanced Sterilization Products (ASP) STERRAD Sterilization Systems and to only decontaminate compatible N95 or N95-equivalent respirators for reuse during the COVID-19 pandemic. These sterilization systems help increase the availability of respirators by allowing decontaminated compatible respirators to be reused so health care workers on the front lines can be better protected when providing care to patients with COVID-19. (May 27, 2020) FDA issued two guidance documents (one new guidance and one revised guidance) for industry to help address potential shortages of face masks, surgical masks, respirators, and face shields for use during the COVID-19 public health emergency: Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Face Masks and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised) (May 27, 2020) Drugs and biologics: Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications — Questions and Answers (May 26, 2020) The FDA is committed to providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid COVID-19 response efforts. FDA has issued more than 50 COVID-19-related guidances to date.