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FDA Developing New Pathway for Device Clearance

NEW YORK (GenomeWeb) – The US Food and Drug Administration said today that it is altering the way it provides 510(k) clearance for medical devices, including in vitro diagnostic products, and that the new clearance pathway will rely less on older predicate products already on the market.

"We believe that where appropriate, new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria," FDA Commissioner Scott Gottlieb and its Director of the Center for Devices and Radiological Health Jeff Shuren said today in a joint statement. "We're pursuing these changes to help keep pace with the increasing complexity of rapidly evolving technology."

Within its 510(k) pathway, the FDA has been clearing devices that show substantial equivalence to products it had already cleared. Some of the predicate devices were cleared soon after 1976 when the agency began regulating medical devices.

Advances in material science, digital health, 3D printing, and other technologies continue to drive invention in medical devices, and it is "vital that the FDA's regulatory approach continue to evolve and modernize to safely and efficiently advance these opportunities," the FDA executives said.

Data show that nearly 20 percent of current 510(k)s are cleared based on a predicate that's more than 10 years old. "That doesn't mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies," Gottlieb and Shuren added.

To advance its goals, the agency is considering making public on its website a list of cleared devices that have demonstrated substantial equivalence to older predicate devices. It is considering focusing on predicates that are more than 10 years old as a starting point, so that the public is aware of those technologies. Before proceeding, the agency is seeking public feedback on whether it should make public those devices or those manufacturers who make technologies that rely on predicates that are more than 10 years old; whether other criteria should inform its point of reference; and whether there are other actions it should take to promote the use of more modern predicates.

The FDA said that it is developing proposals to potentially sunset certain older predicates and promote the use of more modern predicates. To achieve some of the goals related to this program, the agency said it may need to seek guidance from Congress.

The FDA also noted that in early 2019, it anticipates finalizing guidance and establishing an alternative 510(k) pathway that would become the primary way for clearing devices eligible for review.

Rather than looking to the past as a baseline for safety and effectiveness, the new premarket review would be based on a contemporary baseline that looks to the future and can be updated as technologies advance, the agency said.