After a 2009 study classified the FDA's approval process for cardiovascular devices as inadequate and called for the agency to use more evidence from randomized controlled trials (RCTs), a letter featured in the April 28 Journal of the American Medical Association suggested that such an approach is unrealistic and could result in delays in bringing products to the marketplace.
The letter from David F. Kong, MD, of the Duke University Medical Center, in Durham, N.C., comes in response to a study published in JAMA Dec. 23/30, 2009, where Sanket S. Dhruva, MD, of the University of California, San Francisco, and colleagues reviewed clinical data from 2000 to 2007 that the FDA used to assess PMAs.
According to Kong et al, because preclinical data and experience can form objective performance criteria and standards, using “prospective, contemporaneous controls” instead often neglects these associations.
“We believe that the premise of [Dhruva's] review—that the normative standard for ascertaining device safety and effectiveness should be multiple, randomized, double-blinded, prospectively controlled clinical trials that are compelling in themselves—greatly oversimplifies the realities of medical device development and regulation,” the letter stated.
“Inefficient approaches can unduly delay U.S. access to devices otherwise available worldwide, which itself presents a safety concern,” said Kong.
The author stated that in 2006, Congress said that the agency must implement more rigorous methods to assure device safety.
"The [systematic] review [by Dhruva et al] isolated the statistical dimension from the more complete and complex decision making that engenders reasonable assurance of safety and effectiveness and protects public health," wrote Kong. "How much risk, benefit and uncertainty are reasonable for approval devices is a challenging calculus that defies such constructs," he concluded.