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On September 19, 2019, FDA issued a guidance document, “Safety and Performance Based Pathway,” describing an optional pathway for medical devices with well-understood safety and performance profiles. The guidance signals FDA’s willingness to implement a more modern approach under the arcane 510(k) premarket pathway.

Pathway Framework

Under the Federal Food, Drug, and Cosmetic Act, substantial equivalence is rooted in a comparison between a new device and predicate device. Under the traditional 510(k) pathway, FDA reviews data from a direct comparison between the new device and a predicate device (or devices). Under the new Safety and Performance Based Pathway, FDA could instead find substantial equivalence based on data demonstrating the new device meets safety and performance standards identified by FDA. Performance criteria and expectations may be described in FDA guidance, FDA-recognized consensus standards, and/or special controls.

The guidance expands the concept of the Abbreviated 510(k) Program for medical devices. The Abbreviated 510(k) submission program relies on the use of guidance documents, special controls, and FDA-recognized consensus standards to facilitate 510(k) review.

Through this new guidance, the Center for Devices and Radiological Health (CDRH) is continuing to adapt, albeit incrementally, in response to the evolving medical device landscape. Jeff Shuren, M.D., director of CDRH, commented that one of the goals of the Safety and Performance Based Pathway is “to ensure that the 510(k) program is keeping pace with the important innovations we’re seeing in device development.” He commented that 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.”

FDA intends to maintain a list of device types appropriate for the Safety and Performance Based Pathway on its website, along with information and expectations for each device type. The first four device types eligible for the pathway are: (1) spinal plating systems; (2) cutaneous electrodes for recording purposes; (3) conventional Foley catheters; and orthopedic non-spinal metallic bone screws and washers. FDA published draft guidance documents for each device type and is soliciting feedback from industry not only to finalize the guidance documents, but to expand the pathway for other device types.

Moving Forward

CDRH intends to expand this new, optional pathway to other device types. Companies can shape the development of the pathway by engaging with FDA through comments on the guidance documents. While the new pathway does not provide a pathway for novel devices, it does show the Center’s continued efforts to update its approach to substantial equivalence determinations, which inherently relies on outdated technology.