FDA Looks to Establish Certification Program for Device Manufacturers

The U.S. FDA is looking to establish a voluntary certification program for device manufacturers that meet specific manufacturing and product quality requirements. It’s a move, FDA Commissioner Scott Gottlieb says, that will streamline the process for “introducing innovations” in medical device manufacturing.

“In turn, this program would encourage device manufacturers to make investments to re-tool their manufacturing processes in ways that can facilitate manufacturing innovation, encourage investment in new production methods and materials, and lead to better medical products,” Gottlieb said in a statement.

“This more modern and nimble framework would make it more efficient for device developers to innovate manufacturing processes in ways that can allow devices to better meet the needs of patients and the expectations of providers—such as through intelligent, automated processes that monitor and record manufacturing quality metrics, incorporating features and technological characteristics that can contribute to better options and higher quality that achieves their clinical purpose,” he added.

Even so, the FDA is already collaborating with key industry stakeholders via the Medical Device Innovation Consortium to establish the parameters of the certification program. Third-party certifiers need not worry, however, Gottlieb maintained: The FDA plans to recognize these entities and “offer regulatory incentives” to manufacturers who obtain certification for their quality practices.

“These actions would increase manufacturing innovation, accelerate availability of high-quality devices to patients and foster a competitive marketplace around device quality…that would advance device innovations, reduce manufacturing costs, and improve the quality and safety of medical devices,” Gottlieb said in a statement.

After all, he said: “As medical devices become more complex—and given the frequent modifications made to devices— spurring advanced manufacturing and creating a competitive marketplace for device quality is critical for both driving technological innovations and assuring patient safety.”