Antimicrobials and Microbes Indoors: How to Best Promote Indoor Environmental Quality
****!!!!****!!!!*** "47:00 ...designed to inhibit the growth and persistence of bacteria and enveloped viruses on textile surfaces." "1:10:00 [Re. use of chemical disinfectants] I would like to see more research in this area and in the meantime excercise restraint." "1:11:00 resistant fungal infections"
****!!!!****!!!!**** "In implementing this mandate, EPA is not limiting its review to new claims that product manufacturers have made directly in response to the pandemic. Rather, EPA is considering the totality"
Series 810 - Product Performance Test Guidelines | US EPA
****!!!!****!!!! {Registration test requirements for sanitizers, disinfectants, etc} "generally intended to meet testing requirements for the effectiveness of pesticide products under FIFRA"
Efficacy Data and Labeling Requirements: Air Sanitizers | US EPA
****!!!!****!!!!**** (1980) "Requirements apply to products with label claims for the treatment of air to reduce the numbers of airborne microorganisms." "claims of value in preventing or treating diseases, or providing any other health protection, whether expressed or implied, are not acceptable. Claims must clearly indicate the mitigating nature of the activity, such as "Temporarily reduces the number of airborne bacteria."" "The label directions for use of air sanitizers must state: That application be made in closed spaces ("Close all doors and windows; close air vents or turn off air conditioners.")."
"A scientist or team of scientists, depending upon the size of the study, will be assigned to the project and begin to work directly with the study sponsor to define parameters or develop a protocol if necessary. Each device is unique and should be tested in a manner that best simulates actual use. At Microchem, the scientists strive to provide innovative strategies to accomplish any testing objective."
Now is the time for infection preventionists to harness the current attention to biopreparedness and use the momentum to build the foundations for strong local programs that can be sustained through future waves of competing priorities.
Global Sodium Chlorite Market Projected to Surpass $282,911.4 Thousand by 2027, and Grow at a CAGR of 4.4% from 2020 to 2027 – Exclusive Business [171 pages] Report by Research Dive
The global market for sodium chlorite is projected to observe substantial growth over the forecast period, owing to the rising usage of sodium chlorite in...
Historical Information about Device Emergency Use Authorizations | FDA
**** {Revoked EUAs for medical devices} This page contains a listing of all the EUAs have been terminated [revoked] and this information is no longer current.
Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency ~FDA
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency - Conduct-of-Clinical Trial-During-COVID-19-QA Updated 05.14.20.pdf
Making Permanent Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency by Exempting Certain Medical Devices From Premarket Notification Requirements; Request for Information, Research, Analysis, and Public Comment on Opportunities for Further Science and Evidence-Based Reform of Section 510(k) Program
****!!!!**** "Notice to permanently exempt or proposing to permanently exempt certain class I and class II medical devices from the premarket notification requirement in section 510(k) of the Food, Drug, and Cosmetic Act, 21 U.S.C. 360(k). Under this notice, the Department is immediately making permanent the exemption of 7 class I device classes from the section 510(k) requirement and proposes to exempt an additional 84 class II and unclassified device classes from the same requirement on a permanent basis. These 91 devices were all subject a 510(k) waiving during the PHE."
