Leaders with the U.S. Food and Drug Administration (FDA) recently published a draft that updates the traditional recommendations for medical devices that are currently available on the market.
The new recommendations are specific to manufacturers as they develop the medical devices. Any time there are changes made to these devices, the manufacturers must inform the FDA of the changes.
The FDA has published a different guidance specific to software devices.
“These draft recommendations are intended to help manufacturers determine when a change is significant enough to warrant FDA review, including major changes or modifications to the intended use that could significantly impact safety and effectiveness,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said. “Medical device technology evolves quickly, and not all changes made to marketed devices alter their safety profile or require our review.”
The new recommendations have been developed using information from people directly involved in the medical devices field.
“The FDA’s approach was informed by the invaluable feedback from key stakeholders, including industry and patient advocates,” Shuren said. “They helped to shape our recommendations to ensure we strike the right balance between safety and effectiveness of modified devices and advancing device innovation.”
