****!!!!****!!!!**** "Pesticide application equipment that is sold separately from the pesticide itself is not a device or a pesticide. For example, a sprayer for a lawn herbicide that is sold separately from the herbicide is considered to be application equipment, which EPA does not regulate." "Device producers or registrants should see our Pesticide Registration Manual, Chapter 13 for information."
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"
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medical devices} This page contains a listing of all the EUAs have been terminated [revoked] and this information is no longer current.
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."
Notice Regarding Matters of Mutual Responsibility – Regulation of Liquid Chemical Germicides Intended for Use on Medical Devices ~FDA and EPA
"Liquid chemical germicides intended for use in conjunction with a variety of articles that fit within the statutory definition of "device," such as operating instruments, medical examining tables, hospital scales, and other hospital equipment, also fall within the definition of "device" because they are considered accessories to these devices."
eCFR :: 40 CFR Part 168 -- Statements of Enforcement Policies and Interpretations: Advertising of unregistered pesticides, unregistered uses of registered pesticides and FIFRA section 24(c) registrations
Test Guidelines for Pesticide Data Requirements--Implementing Alternative Approaches to Traditional Acute Toxicity Studies | US EPA
In evaluating a pesticide registration application, EPA assesses a wide variety of potential human health and environmental effects associated with use of the product.
Cost Estimates of Studies Required for Pesticide Registration July 2019 ~EPA
"EPA maintains the following list of cost estimates of studies required to support a pesticide’s registration. EPA uses these estimates when determining whether a pesticide use meets the economic incentive portion of the definition of a minor use. The estimates were obtained by EPA from independent laboratories and are adjusted for inflation annually, although they may also change when the Agency has new information on the cost of tests that satisfy data requirements. "