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What are the requirements for marketing medical devices in the United States?

This depends on the type of medical device you are intending to market. The FDA has established both general requirements and special requirements. General requirements include establishment registration, device listing, proper labeling and GMP, which are applicable to most devices. Special requirements – such as Pre market notification and Pre market approval – are applicable to most of the class II or class III devices.

  • Class I devices are subjected to general controls, like establishment registration, device listing, and labeling requirements. Some are also subjected to 510 (k).
  • Class II devices are subjected to special controls like performance standards, post market surveillance, patient registries, special labeling requirements, and pre-market data requirements, along with general controls such as establishment registration, device listing, and labeling requirements. Most class II devices are also subjected to 510 (k).
  • Class III devices are subjected to prior market approval (PMA) along with general controls such as establishment registration, device listing, and labeling requirements.

Pragmatic can assist you to classify your medical device and identify the regulatory requirements.

 

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