Author: Taylor Mann

Date: February 05, 2021

CleanSlate UV Update to All Clients on Regulatory Info

Summary

  • CleanSlate UV is a pesticide device regulated by the Environmental Protection Agency (EPA) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 
  • CleanSlate UV frequently monitors and adjusts claims in response to evolving government guidance.
  • The Federal Drug Administration (FDA) Agency has recently clarified that UV-C devices are not considered cleared for disinfection of medical devices or PPE decontamination.
  • We have removed any mention of stethoscopes in marketing or claims materials. 
  • This is a regulatory and marketing change, not a product performance change. As a leader in device hygiene, CleanSlate UV is fully compliant with both the EPA and FDA. We welcome the FDA’s focus on this market.

Full Update

As a technological and scientific leader in the ultraviolet sanitization industry, CleanSlate UV frequently monitors and adjusts claims in response to evolving government guidance.

The CleanSlate UV is a device that uses physical means (ultraviolet-C or UV-C light) to destroy microorganisms, including bacteria and viruses. It is a pesticide device regulated by the Environmental Protection Agency (EPA) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). CleanSlate UV is registered with the EPA under establishment number 92227CAN001. The solution has been validated in academic studies, hospital case studies, and multiple third-party lab studies, with an efficacy of up to 99.9998% against superbugs such as MRSA. All CleanSlate UV efficacy claims comply with the EPA’s requirements for claims on device labels and advertising.

While the EPA regulates pesticide devices, the Federal Drug Administration (FDA) Agency has recently clarified in conversations with CleanSlate UV that UV-C devices are not considered cleared for disinfection of medical devices or PPE decontamination. To our knowledge, the FDA has not released any public communications on the matter. Additionally, CleanSlate UV has not received and is not aware of any warning letters from the FDA regarding its product labeling. We eagerly look forward to formal guidance from the FDA to pursue a regulatory submission in due course. 

With the influx of mislabeled or falsely labeled UV-C products during the COVID-19 pandemic and increase in off-label use, CleanSlate UV welcomes the FDA focus on this market, and further believes that both users and the industry will benefit from considered regulation. UV-C light can be a powerful tool for deactivating pathogens, and an integral part of a wholistic infection control strategy. However, products must also be properly designed, validated and marketed, and we believe that both the FDA and the EPA have an important role to play in this regard.

In light of our dialogue with the FDA, CleanSlate UV has decided to remove non-critical devices from its list of items that can be used with the CleanSlate UV and voluntarily discontinue the use of any marketing materials included mention to personal protective equipment (PPE) decontamination. We recommend that any facility currently using CleanSlate UV as a primary method of disinfection for these items review their protocols, consulting the available scientific and local regulatory information.

Amid growing interest in smartphone hygiene, CleanSlate UV remains focused on developing simple, safe, and effective products. We will provide any further updates in a timely manner, and appreciate all our clients’ continued efforts to enhance their infection control regimes through effective device hygiene.

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Have questions or concerns? Please don’t hesitate to email us at support@cleanslateuv.com

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