Devices

Device Industry Seeks Changes to Special 510(k) Guide

AdvaMed has commented on FDA’s recent draft guidance on “The Special 510(k) Program,” suggesting that the document’s “proposed text may cause unintended consequences and unnecessarily restrict changes in certain device types from being reviewed through a Special 510(k), even though there are well-established methods with clearly defined endpoints available to verify that the modified device will be substantially equivalent to the previously cleared device.” For example, the group asked for additional guidance clarifying changes that are in and out of scope for a Special 510(k) with respect to fundamental scientific technology and intended use/indications for use, according to comments filed with FDA.

Additionally, AdvaMed asked FDA to elaborate on the document’s point that certain changes to the indications for use of a device would be acceptable under a Special 510(k) provided that the overall intended use of the device remains unchanged. “Aside from changes to the existing indications for use, clarify on the acceptability of the addition of new indications for use to a device (to the already 510(k)-cleared, existing indications for use) without changing the overall intended use of the device,” the group said.

In comments submitted by Thermo Fisher Scientific, the company suggested that a flowchart or checklist be added to the guidance document to aid industry in determining when a Special 510(k) is appropriate. “ These charts are especially useful to in vitro diagnostic submitters who have complex IVDs and may not find the examples included in the draft guidance useful as they are focused on various devices and not IVDs,” the company said. In addition, Thermo Fisher asked for an option to have an early consultation meeting with FDA. “This type of meeting would allow the submitter to obtain clarity and therefore decrease the burden on the FDA and industry of having to convert the Special 510(k) to a traditional 510(k), or having a traditional submitted when a special would have been sufficient,” it said. And, it asked the agency to provide examples specific to IVDs about when the guidance may or may not apply.

Meanwhile, comments submitted by the National Center for Health Research urged FDA to delay the guidance in light of recent announcements about the agency’s intent to revamp the 510(k) process. “There is no way to determine how such guidance might change as part of whatever alterations that the agency may choose to make to the overall 510(k) pathway in the future,” the group said. “Such administrative and regulatory changes may take years to finalize... It is therefore premature to develop guidance for industry on Special 510(k) applications.”

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