US regulations on instructions for use

Looking to tackle the US market? Here is an overview of the US regulatory framework and some easy-to-follow instructions on how to achieve product compliance and avoid legal pitfalls.

Text by Ferry Vermeulen Michael Gerrits

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US regulations on instructions for use

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In the EU, a manufacturer can use European harmonized standards to comply with the relevant essential health and safety requirements of the CE marking directives and accordingly affix CE marking. Many of these CE marking directives also set requirements for user’s instructions. Although there are many similarities, the process of product compliance in the US is slightly different from the process of EU compliance.

An introduction to the US federal regulatory framework

Product safety in the US is regulated by various federal agencies. Once Congress has enacted a product safety law, the appropriate federal agency (e.g. the Consumer Product Safety Commission, the Federal Trade Commission, the National Highway Traffic and Safety Administration, et al.) may create the regulations or rules to implement the law. Together, the enabling acts and laws and the final regulations provide a ...