The Food and Drug Administration (FDA) published proposed guidance on April 22nd for a voluntary expedited access program for new high-risk medical devices that are intended to treat or diagnose patients with serious conditions that are unaddressed by approved technology. The guidance, titled “Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Disease or Conditions” (EAP), is characterized by the agency as an attempt to “help patients have more timely access to these medical devices by expediting their development, assessment and review, while preserving the statutory standard of reasonable assurance of safety and effectiveness…” The FDA also noted that the EAP program is not necessarily a new pathway to market, but instead a collaborative approach between the agency and manufacturers to accelerate device availability under the agency’s existing regulations by speeding both development and pre-market review. The EAP program contains features from its Innovation Pathway program, which was piloted by the agency in 2011. An important feature of the guidance is that the FDA intends to work interactively with qualifying device sponsors to develop device-specific data development plans that will outline the data that sponsors intend to collect in support of ultimate device approval.
To qualify for the EAP process, a device must meet the following conditions:
- The device must be intended to treat or diagnose a life-threatening or irreversibly-debilitating disease or condition;
- The device must represent one of the following:
- No approved alternative treatment/diagnostic exists, or
- A breakthrough technology that provides a clinically meaningful advantage over existing technology, or
- Offers a significant, clinically meaningful advantage over existing approved alternatives, or
- Availability is in the patient’s best interest;
- The device must have an acceptable data development plan that has been approved by the FDA.
The proposed guidance is open for public comment for ninety (90) days following publication in the Federal Register on April 23, 2014.