CFR - Code of Federal Regulations Title 21, Subpart G--General Hospital and ******Personal Use****** Miscellaneous Devices, Sec. 880.6890 General purpose disinfectants.

Guidance about the appropriate use of voluntary consensus standards in the preparation and evaluation of premarket submissions for medical devices. {Probably applies to 510(k)s}

"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?"

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.}

Non-binding recommendations

"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."

Details for device labelers on complying with UDI requirements and submitting data to GUDID.

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

"Section 401 of FDAMA19 described certain conditions under which a drug or medical device manufacturer could choose to disseminate medical and scientific information that discusses unapproved uses of approved drugs and cleared or approved medical devices to “health care professionals and certain entities, including pharmacy benefits managers, health insurance issuers, group health plans, and Federal or State governmental agencies,” without such dissemination being considered as evidence of the manufacturer’s intent that the product be used 99 for an unapproved new use. Among those conditions was the expectation that the manufacturer of the product would seek FDA approval for the unapproved new use referenced in the disseminated literature." "FDA recommends that manufacturers employ the following practices if they choose to disseminate scientific and medical publications that include or may include information on unapproved new uses of approved, cleared, or 510(k) exempt products." “it is unlawful for a manufacturer to introduce a drug into interstate commerce with an intent that it be used for an off-label purpose”

"If a firm responds to... unsolicited requests for off-label information in the manner described above, FDA does not intend to use such responses as evidence of the firm’s intent that its product be used for an unapproved or uncleared use. Such responses also would not be expected to comply with the disclosure requirements related to promotional labeling and advertising. "

"...if a firm communicates information that is not contained in its product’s FDA-required labeling but that is determined to be consistent... FDA does not intend to rely on that communication to establish a new intended use. " "Product communications that are consistent with a product’s FDA-required labeling but are false or misleading may subject a firm to enforcement action under the FD&C Act." "FDA views communications that do not trigger the need for a 510(k) to be consistent with the FDA-required labeling, and does not intend to rely on such communications to establish a new or significantly modified intended use, or one that is different from the use for which the product is legally marketed." "How does FDA determine whether a firm’s product communication is consistent with the FDA-required labeling?" ^Different indication; additional patients; conflict with limitations and directions for handling/use; conflict with dosing, use regimen, route administration, or strength^ ^not considered consistent: use of a product to treat different stage, severity, or manifestation of a disease than the product is approved to treat.^ "Therefore, FDA would not consider representations or suggestions in a CFL promotional communication to be false or misleading based only on the lack of evidence sufficient to satisfy the applicable approval/clearance standard." "...nformation should be presented in a way that does not overstate the conclusions that can be drawn from the supporting evidence."

**** "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.

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}

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

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

Aug 2020

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.

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).

"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."

******* "EPA may also consider new active ingredients or new uses for currently registered active ingredients (including higher application rates, new application methods such as fogging and electrostatic sprayers, or use sites such as porous surfaces) for expedited review. Please contact the Product Manager assigned to your active ingredient and/or product to discuss the data needs for these types of applications and whether or how such an application can be expedited."

"EPA recently announced that it is expediting its review of requests from registrants pursuant to the Agency’s Emerging Viral Pathogens Guidance for Antimicrobial Pesticides. This guidance provides a pathway for registrants to make claims in off-label communications that their registered disinfectants may be used against viral pathogens like human coronavirus. Once such claims are approved, they can be made for the disinfectant in off-label materials only, such as technical literature distributed to health care facilities, physicians, nurses, or public health officials, non-label-related websites, consumer information services, and on social media sites. Nothing in this expedited review eliminates the need to comply with FIFRA." "EPA typically enforces FIFRA through stop-sale orders and penalty actions authorized under sections 13 and 14"

"EPA is expediting the review of disinfectants eligible for inclusion on List N as well as applications to add directions for use with electrostatic sprayers to products intended to kill SARS-CoV-2."