EPA Form 8570-4 (Rev.04-2016), Confidential Business Information ~EPA
OMB No.2070-0060; 2070-0174. This form is designed for reporting the ingredients used in the formulation of a pesticide product. It must be completed and submitted with each applicationfor new registration of a pesticide and application for amended registration if the revision involves a formula change.
Disinfection & Sterilization Guidelines for Healthcare Settings ~CDC
***Most EPA-registered hospital disinfectants have a label contact time of 10 minutes. However, many scientific studies have demonstrated the efficacy of hospital disinfectants against pathogens with a contact time of at least 1 minute. By law, the user must follow all applicable label instructions on EPA-registered products. If the user selects exposure conditions that differ from those on the EPA-registered product label, the user assumes liability for any injuries resulting from off-label use and is potentially subject to enforcement action under FIFRA.
Disinfection & Sterilization Guidelines in Healthcare Settings ~CDC
Ensure that the detergents or enzymatic cleaners selected are compatible with the metals and other materials used in medical instruments. Ensure that the rinse step is adequate for removing cleaning residues to levels that will not interfere with subsequent disinfection/sterilization processes. ***Most EPA-registered hospital disinfectants have a label contact time of 10 minutes. However, multiple scientific studies have demonstrated the efficacy of hospital disinfectants against pathogens with a contact time of at least 1 minute. By law, all applicable label instructions on EPA-registered products must be followed. If the user selects exposure conditions that differ from those on the EPA-registered product label, the user assumes liability from any injuries resulting from off-label use and is potentially subject to enforcement action under FIFRA.***
510(k) classification of Disinfectants as Medical Devices ~FDA
CFR - Code of Federal Regulations Title 21, Subpart G--General Hospital and ******Personal Use****** Miscellaneous Devices, Sec. 880.6890 General purpose disinfectants.
Biocompatibility Testing of Medical Devices – Standards Specific Information for the **Accreditation Scheme** for Conformity Assessment (ASCA) Pilot Program ~FDA
Sept 2020. Lab and test standards and requirements.
Guidance on Conduct of **Clinical Trials of Medical Products** during COVID-19 Public Health Emergency ~FDA
"What factors should sponsors consider when deciding whether to change their clinical trial protocol during the COVID-19 public health emergency to include remote clinical outcome assessments?"
Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin | FDA
Oct 20. Devices made with certain GRAS fabrics, etc with direct or indirect contact with skin. {Includes useful info on 501(k) submissions in general.}
Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency ~FDA
Example of in-state modifications to product instructions, allowed via FIFRA Sec. 2(ee) Recommendation
"This recommendation is made as permitted under FIFRA section 2(ee) and has not been submitted to or approved by the EPA. All applicable directions, restrictions, precautions and Conditions of Sale and Warranty on the EPA registered label are to be followed."
Are there any exceptions to the UDI requirements?
Class I devices are entirely exempt from UDI requirements if FDA has exempted them from the good manufacturing requirements of 21 CFR 820. Class I devices that contain a Universal Product Code (UPC) on their labeling and packages are deemed to meet all UDI labeling requirements, but the labelers of such devices are still required to submit data to the GUDID. Other general exemptions include: Individual, single-use devices distributed in single packaging, Veterinary devices not intended for man distributed in single packaging
FDA Announces New Protocol for the Development and Registration of Treatments for Preharvest Agricultural Water | FDA
The U.S. Food and Drug Administration (FDA) announced a new protocol for the development and registration of antimicrobial treatments for preharvest agricultural water, which was developed through a collaboration with the U.S. Environmental Protection Agency (EPA).
Non-clinical studies required for new drug development - Part I: early in silico and in vitro studies, new target discovery and validation, proof of principles and robustness of animal studies
"Historical overview of drug discovery and the non-clinical stages of the drug development process, from initial target identification and validation, through in silico assays and high throughput screening (HTS), identification of leader molecules and their optimization, the selection of a candidate substance for clinical development, and the use of animal models during the early studies of proof-of-concept (or principle). This report also discusses the relevance of validated and predictive animal models selection, as well as the correct use of animal tests concerning the experimental design, execution and interpretation, which affect the reproducibility, quality and reliability of non-clinical studies necessary to translate to and support clinical studies."
