FDA Issues Three New Draft Guidances for 510(k) Submissions

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September 13, 2023

FDA's proposed recommendations address best practices for selecting predicate devices, inclusion of clinical data, and evidentiary expectations for implant devices

On Sept. 6, the Food and Drug Administration issued three new draft guidance documents aimed at modernizing the 510(k) program. Originally established in 1976, FDA's 510(k) program serves as a pathway to premarket clearance for certain non-exempt low- to moderate-risk medical devices. These draft guidance documents stem from FDA's commitment to continually optimize the clarity, predictability, and consistency of the 510(k) process while ensuring patients have timely access to safe, effective, and high-quality medical devices.

Manufacturers can submit a 510(k) to FDA to demonstrate that the device to be marketed is substantially equivalent to a predicate medical device that is already legally marketed and meets specific requirements. Accordingly, 510(k) clearance is rooted in a comparative analysis of the medical device in question and a pre-existing and legally marketed predicate device.

1. Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission

The first draft guidance proposes best practices for choosing a predicate device that are intended to supplement other common considerations for predicate selection. The recommendations include selecting a predicate device that was cleared using well-established methods, that meets or exceeds expectations for safety and performance, that is without unmitigated use-related or design-related safety issues, and that has not faced a design-related recall.

The draft guidance also recommends writing of 510(k) summaries to include how the selection process of the predicate was followed in light of the recommended best practices. Once finalized, this draft guidance is expected to assist manufacturers in selecting appropriate predicate devices and promote transparency to the public regarding the information submitted to FDA to support a substantial equivalence determination.

2. Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions

The second draft guidance aims to clarify and contextualize situations where clinical data may be necessary to demonstrate substantial equivalence in a 510(k) submission. For example, the guidance notes that factors such as different indications for use, newly identified safety risks for the predicate device, or innovation in materials leading to differences in technological characteristics between the new device and the predicate device may prompt the need for clinical data to be generated and submitted for a new device. To illustrate these various situations, the draft guidance includes examples where clinical data may be needed and where it may not be needed to determine substantial equivalence.

3. Evidentiary Expectations for 510(k) Implant Devices

The third draft guidance is intended to serve as a primary resource for implant devices that require a 510(k) and to supplement device-specific guidance documents, if applicable, that may provide further details for a given device type. Specifically, this guidance document clarifies the evidentiary expectations (i.e., non-clinical and performance testing) needed to support 510(k) submissions for implant devices. The guidance also includes recommendations for other content, such as human factors/usability information, clinical performance testing, patient experience information, and proposed labeling.

Next Steps Towards Finalizing the Guidance Documents

On Oct. 26, FDA will host a webinar for industry and other stakeholders interested in learning more about these draft guidance documents and the agency's ongoing efforts to modernize the 510(k) program.

FDA is requesting feedback via written comments in the Federal Register of each notice by Dec. 6. Electronic comments can be submitted via FDA will consider this feedback before it begins work on the final versions of each guidance document.

While the final versions may differ from the current drafts, these draft guidances provide insight on FDA's current thinking and are useful in developing regulatory strategies to prepare for future 510(k) submissions.

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