In order to optimize the standard of clinical studies that support the PMA (premarket approval) submissions for medical devices, the FDA has issued a draft guidance. The FDA (Food and Drug Administration) says its draft guidance aims to help manufacturers and researchers design better quality clinical studies. The Agency is also calling on experts, manufacturers, researchers, and other groups to provide feedback on its proposed guidance.

When deciding on whether to approve PMA applications for Class III medical devices – high risk ones – the FDA says the submissions undergo stringent and rigorous review. The PMA submissions currently have to include comprehensive data on pivotal clinical studies, as well as other information, before approval is considered.

The draft guidance highlights FDA expectations for clinical trial design issues, such as:

  • Choosing the right type of study
  • Minimizing variability and bias
  • Selecting study participants
  • Selecting study sites
  • Setting suitable study objectives

Earlier on this year the FDA announced 25 actions aimed at improving and strengthening the 510(k) process, as well as improving transparency and predictability of regulatory pathways – part of the Plan of Action for Implementation of 510(k) and Science Recommendations. This draft guideline is one of the 25 actions.

Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, said:

“We want to help manufacturers and researchers take the least burdensome approach to getting safe and effective products to market. This guidance will help manufacturers and researchers better understand the FDA’s basic expectations for clinical trials. We encourage researchers to contact the FDA to discuss the most practical approach to studying their device.”

When submitting a PMA application for a medical device, supporting evidence is required. How much supporting evidence depends on the medical device. In the new draft guidance, researchers and manufacturers will more easily be able to design a pivotal study that is “a practical investment of time, effort, and resources and has a high likelihood of demonstrating safety and effectiveness”, the FDA wrote on its web site.

Section 510(k) is part fo the Federal Food, Drug, and Cosmetic Act. Medical device manufacturers have to register or notify the FDA at least 90 days before submitting a product for approval. This is also known as Premarket Notification, PMN, or 510(k). It gives the FDA time to determine whether the medical device is equivalent to an already approved device in one of the three classification categories.

Written by Christian Nordqvist