New FDA Draft Guidance Offers Clarity for 510(k) Requirements

The FDA has released a new draft guidance which explains when clinical data may be needed for 510(k) submissions, an essential explanation of the agency’s policy for the 510(k) program. When finalized, this draft guidance will provide greater predictability as to when clinical data will be needed for these applications, although devices that are covered by existing device-specific guidances are not included within the scope.

This draft does not address circumstances in which post-market surveillance studies will be required, which may be instituted for any one of several reasons. When finalized, the 510(k) clinical data guidance will aid the manufacturers in determining when clinical data will be essential to demonstrating that their device is substantially equivalent to the selected predicate device. The scope of the clinical data draft guidance includes 510(k) applications filed with both the FDA’s Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research.

One of the conditions that may lead to a determination that a new 510(k) device is not substantially equivalent to the predicate is when there are newly identified risks associated with the predicate device. However, the FDA may also find the new device not substantially equivalent when adverse event reports for the predicate device indicate that a known risk is more common than was previously understood. The draft guidance states that the FDA prefers that an applicant select a predicate without known risks, but that clinical data may be required otherwise.

Clinical data may be required when bench testing and/or other non-clinical testing methods are insufficient to establish substantial equivalence. Another potential trigger for the need for clinical data is when the proposed indication for use for the new device differs from that of the predicate device. This is particularly the case when the new indication for use does not fall within the scope of the predicate device’s intended use statement, such as when the new device is intended to treat a different patient population, or a higher-risk subset of a patient population.

Another scenario involving the indication for use statement for which clinical data may be needed is when the new device would be used in an anatomical region not included in the predicate device. Clinical data may be required to address any increase in the risks associated with the device’s use related to this difference in anatomical location.

Differences in technological characteristics may require the sponsor to provide clinical data with the 510(k) application, but only when those differences raise new questions of safety or effectiveness. Any significant changes in the materials used in the device or in the design of the device may suggest a need for clinical data, which also applies to the use of a different energy source for an active device. The draft guidance provides the example of a change in the monoclonal antibody used in an in vitro diagnostic, which may require clinical evidence that the change in antibody does not alter the performance characteristics of the test.

A new 510(k) device can be found substantially equivalent to the predicate when the two devices’ intended uses are the same, but also when the technological characteristics are either the same or when the technological differences do not raise new questions of safety and effectiveness. A new indication for use need not

The 510(k) clinical data draft guidance is one of three released by the FDA in the first week of September for the 510(k) program, including a draft guidance for implanted 510(k) devices.