FDA Proposes New Program for Approval of Medical Devices

On Tuesday, the U.S. Food and Drug Administration proposed their new program, Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions, to help those in need.

The goal of the program is to create a faster approval process for high-risk medical devices that are used to treat patients with certain conditions for which no other treatment options exist. One advantage of the program is that it would allow manufacturers to meet earlier and more frequently with FDA staff to talk about their developments.

The possible inception of this program seems to support a new culture for the FDA. They're more supportive of manufacturers, companies, and investors who are backing treatments and aid for diseases and conditions that have limited-to-no treatment options. For example, just yesterday the FDA was more open with Sarepta Therapeutics in their development of eteplirsen, a drug to treat Duchenne muscular dystrophy. The administration was open to speaking with them about how they can improve their data on the drug, by reinforcing questions and concerns in relation to the studies that Sarepta conducted. Typically, the FDA just stamps "Yes" or "No" before moving on.

Perhaps since new diseases are developing and the ability to keep up with cures and treatments is extremely costly, time consuming, and difficult, the FDA has decided to crack open its doors for those who are trying to better less fortunate sufferers. The newly proposed expedited access program (EAP) is not a new pathway for companies to market; it's a "collaborative approach to facilitate product development under the agency's existing regulatory authorities," according to the FDA press release.

Eligibility requirements for entry into the program state that the medical device must be intended to treat or diagnose life-threatening or irreversibly-debilitating disease or condition. It must also cooperate with subset requirements, which can be found in the same news release.

The FDA believes that the new expedited access program can both help newer and hard-to-come-by devices be available faster and provide an effective avenue for patient safety and appropriate enforcement.

You can read more about the proposed FDA program in this guidance document provided by the administration.