“High risk or novel” medical devices that might transform medicine could clear Food and Drug Administration scrutiny in half the time of the average medical device under a newly proposed regulatory review process.
FDA moves to hasten medical device reviews
The FDA on Tuesday proposed Innovation Pathway, a “priority review” program for new, breakthrough medical devices that could receive premarket reviews within 150 days, or about half as long as the agency takes to consider most premarket approval applications, according to an FDA statement.
The initiative aims to spur the development of such devices. It “will help accelerate the development of and patient access to innovative medical devices, which often fulfill unmet public health needs,” said Dr. Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, in a news release.
The initiative was welcomed by representatives of medical device companies who have complained that the FDA review process has become increasingly lengthy, expensive and unpredictable.
“We believe it is critical that FDA maintain its focus on bringing greater speed and consistency to the current review process and on addressing the full spectrum of concerns that have contributed to unacceptable delays and inconsistencies which needlessly delay patient access to life-saving, life-enhancing medical technology,” Stephen Ubl, president and CEO of the Advanced Medical Technology Association, said in a written statement in response to the new FDA initiative.
The CDRH will hold a public meeting on the proposed review process on March 15.
Send us a letter
Have an opinion about this story? Click here to submit a Letter to the Editor, and we may publish it in print.