Found 137 bookmarks
Custom sorting
****Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the (COVID-19) Public Health Emergency ~FDA
****Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the (COVID-19) Public Health Emergency ~FDA
****!!!!****!!!!**** {510(k) exemptions for COVID.} "FDA considers chemical/physical disinfectant devices to encompass chemical disinfectant solutions used to disinfect medical devices." "Medical devices disinfectors... exempt from premarket review." "during the declared public health emergency, FDA does not intend to object to the distribution and use of sterilizers, disinfectant devices, and air purifiers that are intended to be effective at killing the SARS-CoV-2 virus but do not already have FDA marketing authorization, without compliance with the following regulatory requirements where such devices do not create an undue risk in light of the public health emergency: prior submission of a premarket notification under section 510(k) [and some other requirements]. FDA believes such devices will not create such an undue risk where the performance and labeling elements... are met." "If the device generates ozone, FDA recommends that the manufacturer evaluate whether the product is within the maximum acceptable level of ozone given in 21 CFR 801.415." [****It sounds like chlorine dioxide could be used if stays below regulated air levels. FDA has endorsed ClO2 standards for air related to food processing [ but need to check FDA's approved air concentrations for around people]. EPA has approved safety of air concentrations at specific levels around people.****]
#Emergency#Air#nb1#Pandemic Control#mj1#Registration & Regulation#Accessories & Equipment
·fda.gov·
****Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the (COVID-19) Public Health Emergency ~FDA
Determining If a Cleaning Product Is a Pesticide ~FIFRA, EPA
Determining If a Cleaning Product Is a Pesticide ~FIFRA, EPA
****!!!!****!!!!**** "interpretation of the statutory and regulatory language applicable to products marketed as cleaning products that claim, state or imply that they mitigate a pest." "where a claim or implication is made in connection with the sale or distribution of a cleaning product that its use will mitigate a pest, either by itself or in combination with any other substance, the product would be considered to be intended for a pesticidal purpose and would therefore be required to be registered." "This fact sheet applies to claims made on a cleaning product’s label or labeling or through other means such as web sites, advertising, promotional or sales activities and testimonial claims in connection with sale or distribution of the product. A link on a producer’s website to academic or extension research that demonstrates the pesticidal efficacy of an unregistered product would be considered a pesticidal claim."
#action#Registration & Regulation#Emergency
·epa.gov·
Determining If a Cleaning Product Is a Pesticide ~FIFRA, EPA
COVID-19 Control and Prevention ~OSHA
COVID-19 Control and Prevention ~OSHA
Employers are responsible for complying with PPE standards, including Respiratory Protection. However, OSHA is providing temporary enforcement flexibility. Webpage also includes Guidance, including for specific types of worker groups.
#Air#Emergency#Pandemic Control
·osha.gov·
COVID-19 Control and Prevention ~OSHA