The US Food and Drug Administration (FDA) has proposed a new programme to speed-up access to high-risk medical devices for addressing medical needs that are unmet by current technology.
The proposed expedited access premarket approval application for unmet medical needs for severe conditions (‘Expedited Access PMA’ or ‘EAP’) programme aims to reduce the time associated with product development, as well as time spent on premarket product review.
The EAP programme builds on the FDA’s Innovation Pathway initiative launched in 2011 and the FDA’s experience with expedited review programmes for pharmaceuticals, including accelerated approval and breakthrough therapies, facilitates earlier and more interactive engagement between device manufacturers and the FDA.
The FDA Center for Devices and Radiological Health director Dr Jeffrey Shuren said the agency is excited to offer a proposed programme for expedited access for certain high-risk medical devices.
"The programme allows manufacturers to engage early and often with the agency," Dr Shuren said. "We expect most devices that enter this programme will be in the pre-clinical trial phase."
According to the agency, several criteria will need to be met for a device to receive EAP approval.
Prerequisites for eligibility in the EAP programme include a device designed with the intention of treating a chronic or life-threatening condition for which no alternative treatment exists, or must offer a meaningful advantage over an existing device or approved alternatives. An acceptable data development plan approved by the FDA is also required.
According to the FDA, under the EAP programme, device manufacturers still have to provide a reasonable assurance of safety and efficacy.
The FDA also published a separate draft guidance that outlines the agency’s current policy on when data can be collected after product approval and what actions are available to the FDA if approval conditions, such as postmarket data collection, are not met.
The guidance includes advice on the use of surrogate or independent markers to support approval, similar to the data points used for accelerated approval of prescription drugs.
"To assure that a device is safe and effective and provide timely patient access to breakthrough devices, it’s critical to get the right balance between pre-market data collection and post-market data collection," Dr Shuren added.