Guidance and Reference Materials

"This labeling may pertain to therapeutic, restorative, diagnostic, or cosmetic devices."

"Interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, etc." "Most, if not all advertising, is labeling."

**** "Conflict with labeling means any deviation from instructions, requirements, or prohibitions of registered labeling concerning storage, handling, or use except those outlined below. ... The following exceptions do not apply to section 18 emergency exemptions." "When products with a specific active ingredient have been registered, those products cannot be used for any non-pesticide use that is not listed on the labeling."

Information about applying approved disinfectants for use against COVID-19.

"Pesticide application equipment that is sold separately from the pesticide itself is not a device or a pesticide." "The device may be “misbranded” if labels, labeling, and/or websites for devices including general or specific efficacy claims include any statement, design, or graphic representation that is “false or misleading in any particular.” "Also, please note that some state laws have requirements for devices in addition to those imposed by FIFRA. Some state governments require registration of devices, including submission and review of efficacy data and labeling, before a device can be sold or distributed"

Medical devices used to diagnose or treat COVID-19 include diagnostic tests, masks, gowns, gloves, sterilizers, and ventilators.

Answers to frequently asked questions about registration and listing of medical devices during the COVID-19 public health emergency

Sept 2019

{Includes info on premarket notification (510(k)) requirements}

****!!!!**** {Excellent sources to search}

This guidance provides recommendations for the formulation and scientific validation of reprocessing instructions for reusable medical devices.

{Alternatives possible if business building's air doesn't meet standards: "Commonly used strategies that a small business can implement include offering telecommuting options, shortened or rotating shifts, temporary office relocation and building shutdown during weather extremes.".} Due to hard-fought battles, the sweatshop is just a bad memory in industrialized countries where modern workplaces provide a safe, healthy environment for employees. The air quality and room temperatures in the workplace can enhance or detract from ...

FDA is working with U.S. Government partners, including CDC, and international partners to address the coronavirus disease 2019 (COVID-19) pandemic.

Aug 2020

"Temperature and Humidity: It is desirable to set the thermostat at the higher end of the comfort zone, 75-78ºF and maintain relative humidity between 40-60%." {No explanation of benefits}. HVAC&R systems play an important role in minimizing the spread of harmful pathogens, and ASHRAE is ready to provide technical resources and answer questions.

Includes calculations

The Pesticide Environmental Stewardship Program is a voluntary membership program that promotes the adoption of innovative, alternative pest control practices such as Integrated Pest Management. PESP has three membership tiers: Bronze, Silver, Gold.

2013. Concerned that fogging/misting products may not be as effective as claimed, and we want to ensure that these fogging/misting products are accurately labeled. Request for efficacy data, or revision of claims.

Exempt from the effectiveness requirements of Sections 514 and 515 of the FD&C Act and is subject to certain profit and use restrictions.. The Humanitarian Device Exemption Program provides a regulatory pathway for medical devices intended for diseases or conditions that affect small populations.

Food and Drug Administration Modernization Act (FDAMA) added the De Novo classification pathway under Section 513(f)(2) of the FD&C act, establishing an alternate pathway to classify new devices into class I or II that had automatically been placed in class III after receiving a Not Substantially Equivalent (NSE) determination in response to a 510(k) submission. In this process, a sponsor who receives an NSE determination may, within 30 days of receiving notice of the NSE determination, request FDA to make a risk-based classification of the device under section 513(a)(1) of the act. In 2012, section 513(f)(2) of the FD&C act was amended by section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA), to provide a second option for De Novo Classification. In this second pathway, a sponsor who determines that there is no legally marketed device upon which to base a determination of Substantial Equivalence may request FDA to make a risk-based classification of the device under section 513(a)(1) of the act without first submitting a 510(k).

Food legislation in the European Union and elsewhere includes both hazard- and risk-based approaches for ensuring safety. In hazard-based approaches, …

"Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual [cosmetic] products or ingredients. The law also does not require cosmetic companies to share their safety information with FDA."