CDRH head Dr. Jeffrey Shuren says a Northwestern University survey on the FDA's 510(k) review of medical devices highlights actions the agency is already taking to improve the program.
Dr. Jeffrey Shuren, head of the FDA's medical device arm, said a Northwestern University survey on the 510(k) clearance program "validates actions we are already taking" to improve the regulatory path for almost all medical devices.
"These efforts may not grab headlines, but they represent true actions we're taking to promote innovation and protect the public health," Shuren told an audience in Washington, D.C. this morning following a presentation of the survey results. "The 510(k) program has to adjust, but it has to adjust properly."
"Large and small companies reported that unclear guidelines, inconsistent implementation, and lead reviewer turnover are contributing to increasing unpredictability of the process," according to the release. "Only 8 percent of survey respondents believe FDA's 510(k) product review process is the most predictable regulatory system, as compared with roughly two-thirds of respondents who stated that Europe's CE marking process is the most predictable."