This week, the Food and Drug Administration (FDA) announced a new plan that would speed up the approval of innovative medical devices that have the potential to dramatically improve patients’ lives.
As reported by the StarTribune, “the so-called Innovation Pathway would aim to review first-of-a-kind devices in five months, which is half the time currently spent reviewing most new devices. Under the program, the FDA would begin corresponding with device scientists in the early stages of development, helping them design studies to show the safety and effectiveness of their devices.”
Most likely, the newly announced program comes in responses to concerns about FDA’s 510(k) program and the agency’s recent release of changes to the program. According to a report from PwC, executives in the medical device industry raised much of the concern because FDA takes “about twice as long to review new devices as their counterparts in the European Union.”
According to the article, “the FDA said an innovative prosthetic arm developed by the Department of Defense would be the first device to use the new system. The device is remotely linked to a microchip in the brain that gives patients near-natural coordination of the prosthetic hand and fingers. It is intended for patients who have suffered spinal cord injury, stroke or amputation.”
The new approval pathway means that “Makers of devices accepted into the new program will receive a written agreement from the agency with a target approval date and a roadmap for the reviewing the product.” A special committee within the FDA made up of experienced scientists and managers will then review the devices.
The agency will hold a public meeting on the program March 15 to gather comments from the public.
The Medical Device Manufacturers Association, which represents smaller medical device companies, commended the FDA’s innovation plan and urged the agency to continue addressing delays in device approval.
“Unnecessary and unreasonable delays for safe and effective products not only hurt innovation, they unfairly punish patients who are relying on America’s med-tech entrepreneurs for help,” said Mark Leahey, the group’s president.
Ultimately, FDA’s new Innovation Pathway has the potential to keep business, research and discovery in America longer. As more and more companies go abroad to set up research facilities and conduct clinical trials, it will be crucial for FDA and related agencies to ensure that industry can have a certain and reliable regulatory system.