FDA Issues Three New Draft Guidance Documents for Medical Devices

Last week, the United States Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) issued three new draft guidances to alter the 510(k) program. According to a statement attributed to Jeff Shuren, MD, JD, and director of the CDRH, these updates will help bolster medical device safety and effectiveness across the US.

According to the statement, a 510(k) is submitted to the FDA under the Food, Drug, and Cosmetics Act before a company intends to market a medical device. Manufacturers are supposed to submit this premarket notification (PMN) approximately three months before the device goes to market.

In an attempt to improve this process and create more robust regulatory practices, the FDA has issued the following drafts:

• Best Practices for Selecting a Predicate Device to Support a Premarket Notification Submission
• Recommendations for the Use of Clinical Data in Premarket Notification Submissions
• Evidentiary Expectations for 510(k) implant devices

Additionally, the FDA statement notes that the organization is “engaging with manufacturers of devices with pre-amendment status to ensure that the appropriate regulatory requirements are met for those devices, given that, over the course of four decades, certain changes may have been made that, in the aggregate over time, could trigger the need for a premarket submission.”

The first document will focus on choosing a predicate device, providing manufacturers with some guidance as they compile 510(k) submissions. The guidance recommends strategies for selecting a predicate device that, at a minimum, meets the expected safety for medical devices in the US. Additionally, predicate devices should not have use-related or design-related safety concerns. The FDA notes that companies should expect to explain how best practice guidelines impacted their selection of a predicate device in their submissions.

The second document outlines what clinical data should be included in the premarket submissions.

Meanwhile, the final guidance focuses on implantable devices, addressing what types of performance testing should be done for implant devices.

The FDA notes, “We intend to finalize these three guidances and use other opportunities to continue to strengthen and modernize other aspects of the 510(k) program to help deliver safe, effective, and high-quality medical devices to patients. This is part of our ongoing commitment to continue protecting and promoting public health.