Hamburg, 10.09.2019, Dr. Silvia van Keulen

A final guidance document was issued by the Food and Drug Administration (FDA) describing the approach when considering uncertainty in risk-benefit determinations related to premarket approval applications (PMA), de novo classification and humanitarian device exemption (HDE) applications. The FDA believes that the described approach „promotes the public health by helping patients have timely access to new medical devices meeting the applicable statutory standard for safety and effectiveness, such that probable benefits of device use outweigh the probable risks and the device will provide clinically significant results in a significant portion of the target population, based on the totality of the valid scientific evidence.“ Several factors are under consideration including the extent of probable risks, benefits, uncertainties and public health needs as well as the patient’s perspective or probable benefits of earlier patient access to the device.

You can access the final guidance document here and if you still want to get more information, the FDA will host a webinar on the guidance.