FDA has published four draft guidance documents detailing the performance criteria certain devices will need to meet to come to market under a modified 510(k) pathway.
The documents will enable companies to win 510(k) clearance by comparing their products to performance criteria set by FDA, rather than by pitting them against predicate devices.
FDA, which published the drafts on Thursday, said the modified pathway can shorten time to market and increase competition.
Last year, FDA outlined plans to modernize the 510(k) pathway by having companies compare their devices to either modern predicates or objective performance criteria. That focus reflected concerns about the effect on innovation and safety of using old predicate devices. Around 20% of 510(k) clearances use predicate devices more than 10 years old.
Now FDA has advanced its strategy by publishing draft guidance documents detailing how four types of medical devices can come to market via the newly minted Safety and Performance Based Pathway rather than through the conventional, predicate-based approach.
"The major benefit is that the pathway will benchmark modern technology against modern standards while, at the same time, offering a potentially more efficient way to demonstrate a new device is substantially equivalent to devices already on the market," Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement.
Shuren said the potentially more efficient approach will help companies get new medical devices to patients sooner and encourage companies to develop products that exceed the FDA benchmarks, increasing market competition and consumer choice.
The four guidance documents cover conventional Foley catheters, cutaneous electrodes for reporting purposes, orthopaedic non-spinal metallic bone screws and spinal plating systems. In each document, FDA defines the intended use and design characteristics of the device class and testing performance criteria.
In the spinal plating text, FDA describes mechanical, sterilization, reprocessing and biocompatibility tests and validations that companies may need to run to show a device performs well enough to come to market. The mechanical testing section of the spinal plating guidance lists three tests such as static compression bending, plus their methodology, performance criteria and additional points companies need to consider.
The other guidance documents feature similar lists of tests tailored to the target device. The result is a set of documents that could enable companies to bring devices to market based on comparisons to objective, FDA-set performance criteria.
FDA is accepting feedback on the drafts until Dec. 19. The agency selected the four device types for the first wave of the new program because it already had performance criteria or consensus standards for those products. FDA said it plans to use feedback on the four drafts to inform the expansion of the program to other classes of device "in the coming months."