FDA Releases Draft Guidance for 510(k) Clearances

Original from: 360DX

US Food and Drug Administration officials on Wednesday released draft guidance outlining the types of predicate device analysis and evidence they will expect in 510(k) clearance applications as they work to modernize the clearance process for medical devices, including in vitro diagnostics.

The documents published on the FDA's website build on the agency's years-long effort to modernize the 510(k) clearance process, which the agency uses to clear devices that show substantial equivalence to devices already cleared. That pathway is commonly used by IVD manufacturers to bring tests and testing equipment to market.

The FDA published three guidance documents on the selection of predicate devices, the use of clinical data and when it is needed to support a 510(k) application, and the evidentiary expectations for implanted devices under the 510(k) process. Agency officials are accepting comments on the draft guidance documents until Dec. 6 at regulations.gov, and the agency will host a webinar for industry and other stakeholders Oct. 26. 

In evaluating 510(k) applications, FDA determines whether a device is substantially equivalent to an approved predicate device that has the same intended use and whether any technological differences between the new and predicate devices raise questions about the safety and effectiveness of the new device.

Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statementthat the guidance documents are meant to provide clarity on complex topics in 510(k) submissions. The average page count per 510(k) submission has more than doubled since 2009 to more than 1,000 pages, which reflects the growing complexity of devices and the increasing need to include clinical data to support substantial equivalence, he said.

"CDRH is continually working to optimize our tools to help ensure patients have timely access to safe, effective, and high-quality medical devices," he said.

In the draft guidance on predicate selection, the FDA recommends 510(k) applicants select predicate devices based on the quality of evidence that had been used to clear those predicates and their safety and performance history since entering the market, including any unresolved safety issues or design-related recalls. The agency said it wants applicants to favor predicates that were tested according to FDA guidance and evaluated using consensus-based standards such as public comment or peer review.

Agency officials also recommended that applicants explain how they selected their predicate devices and how that selection is supported by the best practices outlined by the agency. Shuren said that draft guidance is intended to advance safety and innovation as well as increase transparency about how predicate devices are selected.

In the draft guidance on use of clinical data, agency officials also outlined in new detail the scenarios where 510(k) applications should be backed by clinical data to show a new device is equivalent to a predicate. Those include scenarios in which the new device and predicate device have differences in their indications or technological characteristics, if non-clinical testing alone is insufficient to show equivalence, or if the predicate device has a recently identified or increased risk. 

Shuren said innovations in materials, for example, could lead to technological differences substantial enough to require clinical data in the 510(k) submission.

"As another example, a newly identified risk in the predicate device that impacts the device's safety profile may prompt a need for clinical data for a device of the same type to determine substantial equivalence in light of the new scientific information," he said.

Shuren noted that the draft documents are part of an effort over the prior decade to strengthen the 510(k) program. The CDRH published in November 2018 a proposal on how to modernize the program to advance the review of the safety and effectiveness of medical devices, and, in January 2019, it requested comments on those steps. At the time, that plan was met with optimism and trepidation.

Though agency officials considered at the time developing a public-facing listing of cleared devices that demonstrated substantial equivalence to older predicate devices, Shuren said several comments noted that focusing on older predicates may not optimally promote safer and more effective devices despite the availability of long-term safety and effectiveness data with those devices.

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Source: FDA Releases Draft Guidance for 510(k) Clearances