FDA publishes new guide to device approvals, de novo decisions

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The FDA has released new guidance aimed at helping medical device makers understand how the agency weighs benefits against risks during review for premarket approval (PMA) of Class III devices. The publication also is intended to help FDA staff apply the related device review processes.

The agency generally deems a device Class III if it supports or sustains human life, presents a potential unreasonable risk of illness or injury and lacks sufficient proof of safety and effectiveness. Such devices as implantable pacemakers, automated external defibrillators and HIV diagnostic tests fall into the category.

In announcing the guidance, FDA noted that the de novo review process is available for devices that lack a substantially equivalent predicate but pose only low or moderate risk to patients. De novo is considered a midway point between expedited 510(k) substantial-equivalence reviews and full PMA assessment.

The new guidance includes a worksheet to aid FDA device reviewers as they assess factors that figure into benefit-risk determinations—the magnitude and duration of a risk or benefit, the probability that a patient will experience the risk, the availability of alternative treatments and so on.

“In addition to bringing clarity to our decision making for industry, this guidance will provide our reviewers with uniform and consistent guidelines to assess probable benefits and risks,” said Jeffrey Shuren, M.D., director of FDA’s Center for Devices and Radiological Health (CDRH).

Shuren also said the guidance offers manufacturers greater predictability, consistency and transparency on FDA decision-making “while allowing manufacturers and the FDA to use a common framework for benefit-risk determinations.”

CDRH reviewers are to begin applying the guidance to incoming PMA and de novo submissions May 1.