FDA Moving To Bring Medical Software To Market Faster
The U.S. Food and Drug Administration (FDA) on Thursday announced a pilot program to accelerate the approval of new medical software products.
New Medical Software Certification Protocols
Consequently, Nine companies will participate in the Software Pre-certification Pilot Program and advise on types of expedited pre-certification.
Currently, certification requirements are time-consuming prolong medical software products getting to patients.
Furthermore, excessive regulation prevents updated software getting to market quickly.
FDA commissioner Dr. Scott Gottlieb says, “We need a regulatory framework that accommodates the distinctive nature of digital health technology, its clinical promise, the unique user interface, and the industry’s compressed commercial cycle of new product introductions”.
Most relevant, the FDA also will use third parties to assist on pre-certifications, which will allow the FDA to focus on assessing higher risk technologies.
Finally, The Pre-certification Pilot Program is part of the FDA Center for Devices and Radiological Health’s Digital Health Innovation Action Plan, an initiative to accelerate bringing new digital health technologies to patients.
Patients and Vendors both win!