Clinmark supports conducting of clinical trials of medical devices / in-vitro medical devices and their registration also outside the European Union. Placing a medical device and in vitro medical device on the market in the United State requires submitting of the registration applications to the US Food and Drug Administration (FDA). Depending on the class of the medical device, there are different submission requirements. For Class I medical devices, it is very likely that no FDA Premarket Approval (PMA) or Premarket Notification (510k) will be required. For Class II medical devices, most require 510 (k) submission; in which they must be proved to be as safe and effective, that is, substantially equivalent, to a legally marketed medical device. While most class III devices require PMA. We would be happy to help you with the classification and selection of the submission pathway for your medical device and assist you throughout the process.
Sometimes a clinical trial must be conducted to obtain clinical data for the FDA registration process under the PMA or 510 (k). Prior to commencement, clinical trials of a high-risk medical device must be approved by the FDA and the Institutional Review Board (IRB), and for a negligible-risk medical device only by the IRB. The extensive knowledge of our experts will allow you to investigate your medical device in a safe and efficient manner and lead to reliable clinical data necessary for registration to the FDA.
