Evidence Limited for Most High-risk Device Approvals
Written by Editor   
Tuesday, August 18, 2015 12:00 AM

The quality and amount of evidence used by the US Food and Drug Administration (FDA) to support bringing high-risk devices to market varies greatly, new research indicates.  "[M]ost devices have been or will be evaluated through only a few studies, which often focus on surrogate markers of disease in small numbers of patients followed up over short periods of time and study indications that differ from the original FDA-approved indication," the authors write.

A study found that nearly all devices the authors studied from 2010 to 2011 were cleared on the basis of two studies: one pivotal study (studies that served as the basis of FDA approval) and one nonpivotal study. Nonpivotal studies are typically conducted to assess device feasibility, enrolling a limited number of patients to examine performance and guide premarket development and clinical use.

In the United States, the FDA most often grants marketing approval through the premarket approval pathway for high-risk medical devices, which the authors describe "as those that support or sustain human life, prevent illness, or present potential, unreasonable risk to patients.” 

The current study shows that between 2010 and 2011, the FDA granted initial marketing approval for 28 high-risk therapeutic devices through the premarket approval pathway.  Ten of those devices (35.7%) were recalled at least once, with 1 (3.6%) being the subject of a class 1 recall, meaning it presented the highest risk (reasonable probability of serious health problems or death). One device was voluntarily withdrawn from the market.

Source:  http://www.medscape.com/viewarticle/849349