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The US Food and Drug Administration (FDA) regulates and supervises the safety of medical devices and radiation-emitting products.

The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms engaged in manufacturing, repackaging, relabeling, and/or importing medical devices sold in the United States. CDRH also ensures the safety and effectiveness of medical devices, as well as protecting against unnecessary exposure to radiation-emitting products.

FDA classifies medical devices into three classes – Class I, Class II, and Class III. The class of a device identifies the level of regulatory control necessary to ensure the safety and effectiveness of a medical device, as well as the applicable marketing process in order to obtain FDA clearance/approval. Class I devices are considered “low-risk”, Class II devices require “general controls and special controls”, and finally, Class III devices require pre-market approval (PMA).

From medical device classification and establishment registration to necessary submissions, Provision Consulting Group provides all of the services necessary to enter the U.S. marketplaces with your medical devices.

medical devices
Provision FDA Medical Device Consulting Services Include:
  • Product classification and product code

  • FDA registration and product listings

  • 510(k), De Novo, PMA submission 

  • US agent services 

  • Regulation training

  • FDA inspection consulting

  • Product label review and graphic design support

  • Regulatory compliance

  • Perform critical reviews of prepared submissions

  • Inspection and warning letter response

  • Initial importer 

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