By Melissa Lind
Last week, the FDA unveiled plans for a new program to speed premarket review and approval of innovative new medical devices that address unmet medical needs. The proposed program would grant manufacturers of such devices greater access to FDA staff, in order to collaboratively develop a strategy for product development and marketing approval.
In a statement released by the agency, Jeffrey Shuren, director of the FDA’s Center for Devices and Radiologic Health (CDRH), said, “The program allows manufacturers to engage early and often with the agency. We expect most devices that enter this program will be in the pre-clinical trial phase.”
The proposed Expedited Access Premarket Approval for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions program (EAP) will specifically address medical devices intended to treat or diagnose serious conditions that currently have no other treatment options. To be eligible for the program, devices must also have an FDA-approved data development plan and meet one of the following criteria for addressing an unmet need:
- No approved alternative treatment/diagnostic exists.
- The device represents a breakthrough technology that provides a clinically meaningful advantage over existing technology.
- The device offers a significant, clinically meaningful advantage over existing approved alternatives.
- Availability of the device is in the patient’s best interest.
Under the EAP, the agency intends to provide an interactive review of the sponsor’s data development plan and — where appropriate and when resources permit — an assigned case manager, access to senior management, and priority review status. In some cases, the program may allow the use of different clinical data than traditional PMAs (e.g., intermediate and surrogate endpoints, two-phase studies, and in vitro diagnostics) or less manufacturing information (e.g., by foregoing certain site inspections).
Some in the industry are taking a wait-and-see position regarding the newly released draft guidance. For example, Bradley Merrill Thompson, an attorney who counsels medical device companies, stated in a recent interview with Health Data Management, “Unfortunately for the vast majority of companies, these initiatives really do not prove to be useful.” He also noted that the FDA’s Innovation Pathway pilot program of 2011 had only a few companies participate.
The FDA is accepting public comment on the draft guidance until July 22, 2014.