FDA Commissioner Dr. Scott Gottlieb today announced plans to add a new voluntary alternative pathway for medical devices which would allow clearance upon demonstration equivalence by meeting objective safety and performance criteria.
Under the new framework, device manufacturers would be asked to meet objective criteria based on FDA-developed standards or guidance documents which “embody the safety and performance criteria that new devices could meet to be cleared under a 510(k).”
The new pathway would be available for pre-specified categories of devices, according to the FDA release, limited to devices which have enough safety and performance criteria to be ably identified.
Manufacturers would have the option of using either this pathway or a traditional 510(k) pathway, according to Gottlieb’s release.
“This regulatory innovation holds tremendous promise to further streamline device review for sponsors and FDA and allow new innovations to get to patients more quickly; to allow more advanced technologies to be efficiently incorporated into new devices; and to foster greater confidence in the FDA’s ability to efficiently evaluate safety and benefits of technologies cleared under this pathway – all while maintaining the same gold standard that we apply to existing review processes. By modernizing the benchmarks by which we evaluate the performance characteristics of cleared devices, we believe it will also enable us to put in place more modern criteria for assessing safety,” Gottlieb wrote, according to the FDA release.
Draft guidance on the new pathway is slated to be released in the first quarter of 2018, the FDA said.