On April 23, 2014, the Food and Drug Administration (FDA) issued Draft Guidance proposing a new program designed to provide earlier access to high-risk medical devices intended to treat or diagnose patients with serious medical conditions whose needs are not met by current technologies. These devices are subject to premarket approval (PMA) applications. The guidance document, entitled “Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions” relates to a program given the same name (Expedited Access PMA or EAP). The draft hints at the FDA’s belief that expediting the development, assessment and review of PMAs, while preserving the statutory standard of reasonable assurances of safety and effectiveness for premarket approval, will give patients more timely access to such devices. The EAP, however, does not provide a new pathway to market, and whereas other medical device programs focus on reducing the time for premarket review, EAP seeks to reduce the time associated with product development.

EAP builds on a previously piloted CDRH program, Innovative Pathway, launched in 2011, and incorporates FDA’s experience with other expedited review programs. A key EAP program feature influenced by Innovative Pathway is the development of a “Data Development Plan,” which describes the clinical and nonclinical data that the sponsor proposes to be collected, as well as a timeline for the development and marketing of the device. The FDA views this as helping to ensure a predictable, efficient, transparent and timely device assessment and review.

Postmarket data also plays a role in the EAP program. FDA intends to work interactively with the sponsor to determine whether certain data may be collected postmarket rather than premarket.

To be eligible for participation in the program, the medical device must:

  • Be intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition
  • Represent one of the following:
    1. no approved alternative treatment/diagnostic exists, or
    2. a breakthrough technology that provides a clinically meaningful advantage over existing technology, or
    3. offers a significant, clinically meaningful advantage over existing approved alternatives, or
    4. availability is in the patient’s best interest.
  • Have an acceptable data development plan that has been approved by the FDA

In addition to the EAP draft, the FDA published a separate draft guidance outlining current policy on when data can be collected after product approval and setting forth enforcement actions available to the FDA if certain approval conditions are not met. Entitled “Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval”, the draft outlines how FDA considers the role of postmarket information in determining the extent of data that should be collected in the premarket setting to support PMA, while still meeting the statutory standard of reasonable assurance of safety and effectiveness.

The FDA seeks public comment on both documents.