FDA Proposes Expedited Access Program for Medical Devices

24 Apr

By Michael Quigley, Research Manager, LSN

mike-2Earlier this week, the FDA announced a new program that intended to provide earlier access to unapproved medical devices for certain patients. The EAP (Expedited Access Premarket Approval Application) program will allow companies to directly engage with the FDA sooner to collaboratively develop a plan for collecting scientific and clinical data in order to get patients safer and more effective devices sooner. The basic objective of the program is to diagnose and treat patients who are suffering from serious conditions and have medical needs that are unmet by current technology.

So, which companies are allowed to apply for the program? According to the FDA, a company is eligible for participation in the program as long as the medical device in question meets these standards:

• It is intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition.

• It is able to meet at least one of the following criteria:

1. The device targets an indication where no approved alternative treatment/diagnostic exists.

2. The device is technology that provides a “clinically meaningful” advantage over existing technology and/or approved alternatives.

3. Availability must be in the patient’s best interest (as determined by the FDA).

• The device has an acceptable data-development plan that has been approved by the FDA.

So what does the EAP program mean for the industry as a whole? One obvious foreseeable impact is the attraction of more direct investment into early stage devices.  This is great news, especially since early stage devices have had a tough time raising capital in recent times.  Moreover, early collaboration with the FDA means more guidance in setting clear clinical endpoints and having a better definition of what data is required to move forward. This increased regulatory transparency will hopefully increase the odds of approval (another checkbox for more risk-averse investors). At this point, the FDA has only released preliminary information on the program, but device companies and investors should keep an ear to the ground, as the details of the new program are released over the coming weeks.

Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm394294.htm

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