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The Food and Drug Administration (FDA) is the federal agency of the United States Department of Health and Human Services for food control and drug registration. Their role is to protect and promote public health. The FDA supervises safety of food, tobacco products, biopharmaceuticals, medical devices, electromagnetic radiation emitting devices and animal food. This equally applies for imported and locally produced products.

Manufacturers of Class II-medical devices (according to US-classification) have to submit a Premarket Notification or the so-called 510(k). In order to receive the FDA-approval, first, an equivalent product category needs to be identified. The new product has to be similar to the already listed one. This is followed by the submission of various proofs and certificated.

FDA-service 510(K)

  • Initial check for product conformity with FDA requirements
  • Process clarification (Special / Abbreviated / Traditional)
  • Specific list of required documents
  • Submitted document assessment
  • Correction list, if necessary
  • Submission file: 510(k) document preparation
  • 510(k)-eCopy
  • Application file submission (with eCopy)
  • Communication with the FDA
  • Deviation correction, if necessary
  • Product listing after FDA approval

 

FDA – registration and listing

  • Initial check for product conformity with FDA requirements
  • Specific list of required documents
  • Submitted document assessment
  • User account opening (incl. yearly FDA-fee)
  • Manufacturer registration at FDA
  • Product listing with FDA

 

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