The U.S. FDA plans to apply its least burdensome principle in deciding when to insist on premarket data in a PMA and when to allow the sponsor to gather additional clinical data postmarket.
Federal law requires the agency to request just enough data to assure a device’s safety and effectiveness and no more, meaning postmarket information may be used to reduce the amount of premarket data. This includes quality systems compliance, MDR reporting and postapproval studies, according to final guidance released Thursday.
The key to deciding how much premarket versus postmarket data is okay is the product’s impact on public health, the FDA says. For example, the agency may agree to accept more postmarket data to hasten approval of devices that address unmet medical needs or if it pertains to uncommon or minor risks. The agency also needs less premarket information to approve devices using technology that’s already well understood, the guidance says.
The balance could also tip in favor of more postmarket data if the device addresses an urgent public health need, such as a diagnostic to detect a spreading epidemic, or when the data is intended to confirm mitigation of known risks, the FDA says. Another reason for collecting postmarket data would be to gather information about a patient population beyond that addressed in the premarket study, the agency adds.
The guidance, Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval, was issued alongside one explaining the FDA’s new Expedited Access Program for devices filling unmet needs. It is expected to help agency staff balance premarket and postmarket information requests for devices on the EAP pathway (see related story).