The Food and Drug Administration (shortly FDA) is the American government agency that releases the clearance for placing on the market food, pharmaceutical, and medical devices.
Focusing on medical devices, procedures for obtaining clearance are diversified depending on the situation: the most well-known way is the one known as 510 (K), applicable for products similar to others already legally marketed in the USA.
From a technical point of view, the FDA requirements are not different from the ones formulated by the Notified body in Europe for releasing the CE Certification of the same device.
Another point of commonality is the increasing alignment at the level of voluntary technical standards. This is a positive evolution of the last years and the manufacturer benefits being familiar with these aspects.
The documents to support the application are prepared with a particular procedure. These procedures require therefore a specific experience directly reached in such activity.
The Studio tau consultancy supports companies intending to export medical devices and in vitro diagnostic devices (IVD) to the USA assisting them:
– in the preparation of the documentation to be submitted
– in the carrying out clinical trials and laboratory tests
according to what is needed to get the approval,
If you have the need for assistance, consultation, or even preliminary information, contact us; we will be pleased to be at your service.