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Who knew that hand sanitizer and bleach are going to be some of the most in-demand products in 2020?  With the advent of the COVID-19 coronavirus pandemic and the exponential increase in demand for PPE (Personal Protection Equipment) products, questions are raised about the effectiveness of these products and the source of those product requirements.  Is there clear guidance?  Is there a clear regulator?

Our product risk management team has been speaking to several trade associations in September 2020 about how to navigate the alphabet soup of federal agencies supervising COVID-19 product distribution.  The biggest takeaway:  How a product is advertised for sale plays a critical role in how it is regulated and by which agency .  The regulatory profile can mean the difference between required manufacturing registration or specific requirements as to product labeling.

The article focuses on the major and most significant players involved in the outlining regulatory requirements for COVID-19 PPE products and the potential for conflicts and confusion. 

COVID-19 Product Requirements

The key regulatory bodies in the United States are:

  • Food & Drug Administration (FDA)
  • Federal Trade Commission (FTC)
  • Environmental Protection Agency (EPA)

The are details the juristidction and responsiblity differences among these agencies as it relates to product requirements for the coronavirus PPEs.

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2020-09-14 The Confusion with COVID-19 Product Requirements The Confusion with COVID-19 Product Requirements

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