De Novo pathwayWe'll see this device Marketed much sooner than anticipated.
08:00 AM EST, 12/30/2020 (MT Newswires) -- Medical device company Titan Medical (TMD.TO)t has received a written response from the U.S. FDA to its Request for Information regarding the regulatory requirements applicable to its robotically assisted surgical device (RASD), the Enos Robotic Single Access System. The FDA has indicated that, based on information to hand, the Enos system is appropriate for classification through the De Novo pathway.
The company says it will likely proceed with a De Novo classification request for its Enos system in place of a 510(k) submission. Should the FDA grant the De Novo classification request, the Class II device would be cleared to be marketed. In addition, a new classification regulation will be established, and the new device may then serve as a predicate device for 510(k) submissions of future devices of the same type.
(The de novo pathway for device marketing rights was added to address novel devices of low to moderate risk that do not have a valid predicate device. A predicate device is cleared to be marketed in the US and may also be used as a comparison for new medical devices.)