The authors suggest that their results indicate that the FDA’s approvals should be based on more rigorous clinical studies, both before and after the devices are available in the market.

“There are much higher standards for the approval of new drugs, whether oral, injectable or even topical,” said Xu. “The important question to ask is: should we really be holding high-risk medical devices to a lower standard of evidence than drugs?”


They acknowledge that in biomedical research, the randomized controlled trial is oftentimes considered the gold-standard of evidence of safety and effectiveness, and unlike drug trials, it may not be feasible to conduct a randomized controlled trial for medical devices, since it involves both the decision to approve a medical device and then monitoring its safety and effectiveness after approval.

“We should still set a higher bar for approval, including meeting successful primary clinical trial endpoints, ensuring sufficient patient sample size, ensuring sufficient length of patient follow up, and blinding when appropriate,” Walter told HCB News.

The researchers believe their results show that FDA should approve devices based on more rigorous clinical studies than the ones that are currently required, both before and after the devices are available in the market. Lastly, they believe that FDA should seek more input from expert advisory committees and rely on higher quality studies.

“The FDA has a very important, very challenging, and very complex job. The goal ... is not to criticize the FDA, or industry for that matter,” Walter said. “As physicians, protecting the safety of our patients is the most important thing we do.”

“We trust that drugs we prescribe have proven their safety and efficacy in well-designed, rigorous clinical studies that meet the FDA’s appropriately high standards. We believe that medical devices are far behind drugs in this context,” she said.

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