FDA Approval

510k Consultants

FDA Consultants- FDA Approval

Before marketing a medical device or health product in the US, or reintroducing a device that has been modified affecting safety or effectiveness, manufacturers or parties of interest need to submit to the Food and Drug Administration FDA a pre market notification 510(k) and demonstrate by performance data and product documentation that it is substantially equivalent to an already marketed device and that no new safety or effectiveness concerns are introduced. In case there is no equivalente product cleared for marketing in the US, a premarket approval PMA submission might need to be followed. In those cases clinical or animal test data might need to be submitted.

Sigma Biomedical provides complete FDA consulting and FDA approval services for 510k submissions, as well as for other medical regulatory affairs needs, such as FDA Quality System Regulations QSR compliance. Sigma's regulatory, engineering and scientific team can efficiently help you register your product with the FDA