1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Regulation

FDA Data: Breakthrough Program Accepted 45% Of Applicants Since 2015

 
• By Elizabeth Orr

Data from the US Food and Drug Administration shows that the agency has granted 853 breakthrough device applications since 2015, out of 1,909 applications. The acceptance rate has varied from 33% in 2016 to 72% in 2017, with acceptance rates in recent years hovering around the 40% mark.

Young businessman breaking through a wall.
• Source: Shutterstock

Interested in the US Food and Drug Administration's breakthrough devices pathway? The odds may not be in your favor. Data from the agency shows that of almost 2,000 applications to the program and its predecessor since 2015, only 853 -- about 45% were granted the designation, with the other applications being either denied or withdrawn.

To qualify for the program, devices must provide more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition and meet at least

More from Regulation

More from Policy & Regulation

Health Secretary Defends Spending Cuts During Senate Hearing On HHS Budget

 
• By Elizabeth Orr

Health and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs.

Tariffs Threaten Medtech Innovation And US Position As World Leader, Whitaker Tells Lawmakers

 
• By Brian Bossetta

During his testimony before US senators on the impact of tariffs on critical supply chains, AdvaMed’s Scott Whitaker said the Trump tariffs could jeopardize America’s preeminence in medtech. Other industry experts echoed similar concerns.

Califf Warns Progress May Be In Danger Due To ‘Decimated’ FDA Staff

 
• By Barnaby Pickering

In Vivo spoke to the previous commissioner of the US FDA about recent ongoings at the agency, and where he believes policy should be directed for patient and industry benefit.