Devices

Safety and Performance-Based Device Pathway

CDRH Office of Product Evaluation and Quality technical guidance specialist Jason Ryans says the purpose of the new safety and performance-based pathway is to establish a voluntary more modern 510(k) pathway for demonstrating safety and effectiveness for certain well-understood devices. Speaking during a CDRH 11/7 Webinar, Ryans said that to facilitate a more modern paradigm, FDA intends to expand the existing 510(k) program to allow manufacturers of certain well-understood devices to use objective performance criteria established or recognized by the agency to demonstrate substantial equivalence.

“FDA will ensure that the objective criteria represent performance that is equivalent to modern technology,” he said. “This approach will provide more direct evidence of the safety and performance of a device and better information for patients and providers to make well-informed healthcare decisions. Additionally, it will provide an opportunity for device developers to demonstrate that their product meets or exceeds these modern performance criteria as well as the ability to do so and in a more straightforward and streamlined manner.”

The framework for the voluntary pathway was first outlined in a 4/2018 draft guidance and then finalized 2/2019 and updated 9/2019. The pathway is optional and Ryans said it will not impede the use of other 510(k) pathways, including the traditional, special, and abbreviated. “Submitters will demonstrate that a new device meets FDA-identified performance criteria to demonstrate that the device is as safe and effective as a legally marketed device,” he said. “If a legally marketed device performs at certain levels relevant to its safety and effectiveness, FDA can find that the new device is as safe and effective as a legally marketed device. Instead of reviewing data from direct comparison testing between the two devices, FDA can support a finding of substantial equivalence based on data showing the new device meets the level of performance of an appropriate predicate device.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome