CHI releases new white paper on 510(k) review process

California Healthcare Institute today announced the release of a new white paper titled "Upcoming Changes to the 510(k) Process: New Approval Pathways and the Impact on Medical Device Development and Innovation."

“Upcoming Changes to the 510(k) Process: New Approval Pathways and the Impact on Medical Device Development and Innovation.”

The 510(k) review process is a key regulatory pathway for the introduction of medical technologies. It allows medical device developers to bring new products to market based on data from existing devices, known as predicate devices that have already been approved as safe and effective. Most important, it is a long-standing, proven mechanism for ensuring timely access to new and improved treatments for patients in need. In the last year alone, 3,000 new devices were approved under the 510(k) process, benefiting physicians and the patients in their care.

This white paper recognizes the importance of the U.S. Food and Drug Administration (FDA) 510(k) system to the future of medical technology innovation and considers the potential impacts changes to that system would have on the industry. The report highlights key biomedical industry leaders and former FDA officials who convened in late July to discuss the regulatory environment and its potential impact on the medical device industry in California. Among others, they include former FDA Chief Counsel Peter Barton Hutt, former Center for Devices and Radiological Health (CDRH) Director David Feigal and ExploraMed Development LLC CEO Dr. Josh Makower.

"California is the world's leader in the development of innovative medical technology," said David Gollaher, Ph.D., president and chief executive officer of CHI. "It is through this important regulatory pathway that new and improved medical devices are introduced in a timely manner to patients in need."

Earlier this month, CHI submitted formal comments to the FDA regarding the CDRH 510(k) Working Group Preliminary Report and Recommendations, which could transform the 510(k) regulatory process, greatly affecting innovation, jobs and, ultimately, public health. Changes to the current process have potential to disrupt the fragile ecosystem that balances academic research, risk capital and the dynamic medical marketplace.

The comments came in advance of the last of three nationwide town hall meetings moderated by CDRH Director Dr. Jeffrey Shuren. Gollaher addressed the crowd gathered Oct. 7 in Irvine, noting FDA's recognition that changes to the 510(k) medical device approvals pathway could impact investor interest in the industry, while also acknowledging the sector's need for certainty, predictability and clarity surrounding the medical device approval process.

"We look forward to continuing the dialogue with the FDA and Dr. Shuren about improving the regulatory processes, which could lead to increased efficiencies and greater predictability for medical device innovators," Gollaher said.

In an effort to educate policy makers about the depth of the problem and to effect change, CHI also recently announced it has partnered with Boston Consulting Group (BCG) to analyze historical data on FDA approval times for drugs and devices. These data, and the narrative around them, will also serve as the basis for direct conversations with leadership at the FDA on ways of improving the regulatory environment in a way that maintains safety but also improves predictability, consistency and transparency to promote innovation and patient care. CHI will be releasing the first of three reports in mid-November.