FDA Provides Guidance for Medical Device Studies

In an effort to provide more clarity to medical device manufacturers and reviewers, yesterday the FDA released a proposed guidance on how clinical studies should be designed in order to help secure the agency’s approval.

The proposed guidelines focuses on the agency’s expectations for clinical trial design and how benefit-risk determinations are made when evaluating medical devices for pre-market approval. The guidelines provide manufacturers with advice on minimizing issues like data bias and variability, as well as setting the appropriate objectives and selecting the right type of study, site and participants for medical device clinical studies.

“We want to help manufacturers and researchers take the least burdensome approach to getting safe and effective products to market,” said Jeffrey Shuren, MD and director of the FDA’s Center for Devices and Radiological Health. “This guidance will help manufacturers and researchers better understand the FDA’s basic expectations for clinical trials.”

Hopefully the guidance will provide the clarity that manufacturers and the FDA need to ensure that safe and effective medical devices can make it to the market as quickly as possible.