FDA Wrestles With Device Uncertainty in New Draft Guidance

The FDA may be willing to accept some uncertainty about a proposed medical device’s safety if sponsors will carefully collect data after the device hits the market, the agency says in a new draft guidance.

The 21st Century Cures Act requires the FDA to fast-track approval for breakthrough devices when the approval is “in the best interest of patients.” But fast-tracking breakthrough devices—or devices that target extremely rare diseases—may mean that regulators have to accept some unanswered safety questions.

The 22-page draft guidance is the FDA’s attempt to wrestle with that uncertainty for breakthrough and rare-disease devices.