COVID-19 Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers (FDA, 2020)
What your doctor is reading on Medscape.com:
APRIL 09, 2020 — An enforcement policy for sterilizers, disinfectant devices, and air purifiers was published in 2020 by the Food and Drug Administration (FDA).[1]
Due to the COVID-19 pandemic, it is necessary to maintain an adequate supply of sterilizers, disinfectant devices, and air purifiers to reduce the risk of viral exposure for patients and healthcare providers.
The FDA does not intend to object to the distribution and use of sterilizers, disinfectant devices, and air purifiers that do not already have FDA marketing authorization.
Modifications to these devices typically require premarket authorization by the FDA, but due to the pandemic and to ensure availability of equipment, the FDA does not intend to object to limited modifications.
The FDA recommends any modifications to sterilizers, disinfectant devices, and air purifiers be designed, evaluated, and validated in accordance with FDA-recognized standards.
If modifications are made, the FDA recommends that sterilizers, disinfectant devices, and air purifiers include labeling that helps users better understand the modifications.
Medscape Medical News
Sources
Food and Drug Administration. Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff. March 2020. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-ventilators-and-accessories-and-other-respiratory-devices-during-coronavirus
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