Over at MD+DI, Thomas Blair writes:
With the 510(k) controversy simmering at a low boil for now, FDA has introduced yet another pathway to get new medical devices to market—an “innovation” pathway, to be precise.
 
The agency’s proposed “Innovation Pathway” would put “pioneering medical devices” on the fast-track to review, with CDRH drawing up a plan to assess such products early in the development process. Approval could then come within 150 days. The proposed program, the details of which are covered in the agency’s press release on the subject, will be discussed at a public meeting set for March 15. In the meantime, the agency announced that a “brain-controlled” prosthetic arm being developed by the Defense Department will be the first device to go through the new process.
 
Notice that the first medical device being considered for the new process contains sophisticated electronics. A microchip implanted in the brain will record and decode signals to neurons that control muscles linked to the prosthesis. (Actually, it sounds a little like what Julien Penders described to me last week.) The fact that a medical electronic device is the guinea pig for the new innovation pathway is somewhat telling, if only because It is indicative of the trend toward smart devices that can do cool things thanks to embedded circuitry. But other OEMs in this space should watch—closely—the procedural steps and outcome of this pioneer device's path to approval. —Lawrence Lloyd