FDA details proposed 510(k) modernization with trio of draft guidances

The US Food and Drug Administration (FDA) has announced new steps it is taking to modernize the 510(k) program, which include updates on its Safety and Performance Based Pathway, electronic Submission Template And Resource (eSTAR) program and draft guidances concerning specific components of the 510(k) program.

FDA’s Safety and Performance Based Pathway, launched in September 2019, was designed to allow sponsors with well understood device types to demonstrate safety and efficacy of their devices through FDA-identified performance criteria. The agency noted ten final guidance documents have been released since the final guidance for this pathway was released, and include guidances on spinal plating systems, orthopedic non-spinal metallic bone screws and washers, magnetic resonance receive-only coils, cutaneous electrodes for recording purposes, conventional foley catheters, fracture fixation plates, surgical sutures, denture base resin, facet screw systems and soft (hydrophilic) daily wear contact lenses. More device-specific guidances for the Safety and Performance Based Pathway are on the way, FDA said.

The eSTAR program, which began as a pilot program in February 2020, is also undergoing changes. Starting in October 2023, non-exempt 510(k) submissions must be submitted through eSTAR, the agency said. Those devices exempt from eSTAR include original submissions and subsequent submissions to original submissions for traditional, special, and abbreviated 510(k)s, the agency noted in a final guidance from September 2022.

FDA’s announcement also highlighted the publication of three new draft guidance documents proposing recommendations about different aspects of the 510(k) program. The first, concerning best practices for selecting a predicate device, note that a predicate device should be cleared using “well-established methods,” meets or exceeds safety and performance expectations, does not have “unmitigated” safety issues related to use or design and is not associated with a design-related recall.

“The draft guidance explains how use of these best practices is expected to benefit manufacturers, the FDA, and public health, and provides examples of how to apply these best practices,” the agency wrote in its announcement. “The FDA believes use of these best practices outlined in this draft guidance, once finalized, will encourage the evolution of safer and more effective medical devices in the 510(k) Program over time.

A second draft guidance expands FDA’s policies on when clinical data on substantial equivalence is necessary in a 510(k) submission. FDA’s draft guidance describes the appropriate use of clinical data in this process and outlines a number of scenarios where substantial equivalence clinical data is required, such as when the indications for use are different, there are differences in technological characteristics, if substantial equivalence is not determined through non-clinical testing and if there is a new risk or increased risk from a predicate device.

“The FDA believes these recommendations, once finalized, will enhance predictability, consistency, and transparency in the use of clinical data in 510(k) submissions and lead to the appropriate data the FDA needs to make substantial equivalence determinations to assure the safety and effectiveness of devices,” the agency said.

The third guidance provides evidentiary expectations for 510(k) devices, specifically containing recommendations for 510(k) implants such as general considerations, non-clinical recommendations, human factors and usability, clinical performance testing, patient experience information, labeling and other recommendations. FDA said the draft guidance should apply to all 510(k) devices and is intended to help sponsors with design and execution of performance testing for 510(k) submissions and reinforces that patient safety is the most important component of improving device safety. “The FDA expects this guidance, once finalized, will enhance transparency, consistency, and predictability of the 510(k) premarket review process for implanted medical devices,” the agency said.

“We intend to finalize these three guidances and use other opportunities to continue to strengthen and modernize other aspects of the 510(k) Program to help deliver safe, effective and high-quality medical devices to patients. This is part of our ongoing commitment to continue protecting and promoting public health,” Jeff Shuren, director of FDA's Center for Devices and Radiological Health (CDRH), said in a statement published alongside the agency’s announcement.

In addition to the draft guidance documents, FDA said it is working in parallel with manufacturers who have devices in a preamendment status to ensure devices that meet the requirements for preamendment status remain safe and effective and do not need a premarket submission. The agency devices a preamendment device as being on the market before May 28, 1976, not having significantly changed since that time, and not subject to a regulation that would require a premarket submission.

“The FDA recommends that manufacturers of preamendments devices compare the currently marketed version of the device to the preamendment version of the device to determine if the marketed device has been changed or modified in a way that could trigger the regulatory threshold to require 510(k) submission,” they said. “Manufacturers are welcome to discuss with the Agency a proposed plan for submission and the FDA review of a premarket submission for their device, if appropriate.”

Draft guidance 1, 2, 3

FDA details proposed 510(k) modernization with trio of draft guidances

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