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# More 510(k) Changes Likely: Attorneys
- URL: https://www.fdaweb.com/more-510-k-changes-likely-attorneys/
- Published: 2023-09-19T12:00:00.000Z
- Updated: 2026-09-14T18:57:15.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155358

Three Ropes & Gray attorneys say FDA likely has more significant reforms in mind than the recent three draft guidances to modernize and update the 510(k) medical device approval pathway. Writing in an online [post](https://www.ropesgray.com/en/newsroom/alerts/2023/09/a-step-forward-fda-issues-three-draft-guidance-documents-as-part-of-efforts-to-modernize?ref=fdaweb.com), the attorneys analyze the three draft [guidances](https://www.fdaweb.com/3-new-510-k-guidances/), while suggesting that the agency is considering creating a new pathway to market known as the Voluntary Alternative Pathway (VAP). They say such a pathway would likely give FDA authority to offer a more customized approach to regulating new technologies, and in particular rapidly evolving digital technologies.

“The current thinking is that if this proposal were implemented,” the attorneys say, “it would give sponsors the option to pursue either the flexible voluntary pathway or the more traditional, existing regulatory routes like the 510(k) pathway. Whether this VAP proposal, or other potential efforts to modernize the 510(k) pathway, are likely to gain traction within the executive branch or with Congress remains to be seen. Nevertheless, the recent draft guidance documents are certainly steps on the way to creating broader and more meaningful change.”

The analysis covers the highlights in the guidances that address **(1)** best practices for selecting a predicate device to support a 510(k) submission; **(2)** recommendations for the use of clinical data to support a 510(k) submission; and **(3)** evidentiary expectations for 510(k) implant devices.

The attorneys write that in the predicate device draft, the agency takes a different approach that focuses on predicate devices with certain characteristics, rather than predicate devices of a certain age. It identifies four specific best practices to follow when selecting a predicate device to support a 510(k) submission:

- predicate devices cleared using well-established methods;
- predicate devices that meet or exceed expected safety and performance;
- predicate devices without unlimited use-related or design-related safety issues; and
- predicate devices without an associated design-related recall.

In the clinical data draft guidance, FDA identifies the four most common scenarios where clinical data may be necessary to demonstrate substantial equivalence:

- differences in indications for use;
- differences in technological characteristics;
- when substantial equivalence cannot be determined by non-clinical testing; and
- newly identified or increased risk for the predicate device.

The attorneys say the implants draft guidance is the first to provide generally applicable recommendations for all implant devices for which a 510(k) is required. The draft details the agency’s expectations for an implant device, including indication for use considerations, considerations about the intended duration of implantation, non-clinical testing, human factors and usability testing, clinical performance testing, patient experience information, where relevant, and labeling.