Discussion: View Thread

  • 1.  EPA regulation

    Posted 04-Aug-2020 13:33
    I don't know if anyone has experience with EPA regulations or not,
    We are manufacturing a disinfectant handheld device using UV light and want to have a claim on the label to kill and disinfect surfaces 
    As I know I have to submit to get an Establishment number, but I need to know how to get an approval for the Claims on the device 
    if anyone knows please Help 
    Thanks

    ------------------------------
    YASSER ESTAFANOUS
    Director of RA/QA
    Winter Haven FL
    United States
    ------------------------------


  • 2.  RE: EPA regulation

    Posted 05-Aug-2020 16:33
    Hi, Yasser:

    Your hand-held UV disinfectant device may involve both FDA and EPA regulations. For device portion, FDA's requirements are as the following:  

    To ensure devices do not create an "undue risk," the FDA has outlined specific performance and labeling requirements that must be met. Importantly, manufacturers must document any changes made to the device in the manufacturer's device master record and change control records "and make this information available to FDA, if requested, consistent with 21 CFR 820.30 and 21 CFR 820.180." Manufacturers of all Class II, Class III, and specific Class I devices listed under 21 CFR 820.30(a)(2) must establish and maintain procedures to control the design of the device ensuring that specified design requirements are met. Under 21 CFR 820.30, manufacturers must establish and maintain a design history file containing or referencing the records that demonstrate that the design was developed in accordance with the approved design plan and the requirements under that section. Therefore, under the enforcement policy, any changes to the design or performance of a device would need to be reflected in the design history file.

    For the difference of FDA and EPA governance, the following article described more details which may be useful as your reference for this type of device product: https://www.alston.com/-/media/files/insights/publications/2020/04/fda-epa-disinfectants.pdf

    Li-Chun Tsou