FDA Issues New Guidance for 510(K) Medical Device Approvals

The U.S. Food and Drug Administration (FDA) just issued new draft guidance for 510(K) device approvals. The draft guidance clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission.

Congress gave the FDA authority over medical devices in 1976 and allowed it a quick review process for new devices it deemed were substantially equivalent to already approved medical devices. The expedited process became known as a 510(k) review. In 1976, medical devices played a much smaller role in medicine. In recent years, the 510(k) process has been criticized because the complexity of the thousands of devices on the current market have rendered the expedited process inadequate. In stark contrast to the more intense process for drug approvals, the FDA only mandates that medical device makers simply demonstrate that a device does what the maker says it does, and that the device poses no undue safety risks. Unlike a new drug, a device approved under the 501(k) rules does not have to be shown to be effective.

The 510(k) process is the most common review path to market for lower-risk medical devices; to be legally marketed, a device maker need only submit a premarket notification or 510(k) demonstrating that the new or modified product is substantially equivalent to another legally marketed medical device. But, drug makers often make changes or modifications to a device after FDA clearance; for instance, incorporating new technology or upgrading certain device aspects. Many changes do not require a 510(k) submission. But when the changes could significantly affect the product’s safety or efficacy or constitute a major change to the intended use of the device, another 510(k) must be submitted.

“We are making the regulatory process for medical devices less challenging by better describing our expectations” Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, said in a statement issued by the FDA. “In particular, manufacturers can continue to make innovative improvements to their devices and better plan for any updated submissions. This saves time and money.”

The revised guidance gives direction to device makers and addresses issues concerning software, changing technologies and provides “greater clarity about changes that do not trigger the need for a new premarket submissions,” reported The Heart, and other changes that might trigger the need for a new submission, such as specific kinds of labeling changes, changes in performance specifications, manufacturing changes, and changes in the materials used in the manufacture of the device.

This draft guidance is one of 25 action items listed in the FDA’s Plan of Action for Implementation of 510(k) and Science Recommendations launched in 2011 to enhance predictability, consistency, and transparency of the FDA’s premarket review programs.

The Heart pointed out that the changes will help mitigate some of the mistakes that have occurred in the medical device industry. For instance, pointed out the Heart, the Myxo Ring debacle. HeartWire explained that Edwards Lifesciences has been sued over its improperly selling the Myxo ETlogix annuloplasty ring, as a so-called “investigational” device that was allegedly marketed without premarket notification submission 510(k) clearance. Edwards claimed the clearance was unnecessary because the device was similar to an already cleared version. While the FDA did not agree, it did not sanction Edwards. The new guidance will prevent this sort of inappropriate disregard of the 501(k) process, said The Heart.