CHI responds to FDA recommendations for 510(k) regulatory review process

CHI- California Healthcare Institute today released a statement in response to new U.S. Food and Drug Administration (FDA) recommendations that could transform the 510(k) regulatory review process for new medical devices, greatly affecting innovation and public health in California.

“CHI is pleased that the FDA has recognized its essential role in shaping the environment for biomedical innovation and the need for greater clarity and efficiency in its review processes”

CHI applauds the FDA's Center for Devices and Radiological Health (CDRH) and its director, Dr. Jeffrey Shuren, for developing the recommendations with input from the biomedical community. During a CDRH town hall meeting held late last year in Irvine, Calif., CHI advocated for strengthening the 510(k) review process to provide greater clarity and consistency. CHI is a non-profit public policy research organization, representing leading California academic institutions, biotechnology, medical device, diagnostics and pharmaceutical firms.

"CHI is pleased that the FDA has recognized its essential role in shaping the environment for biomedical innovation and the need for greater clarity and efficiency in its review processes," said CHI President and CEO David L. Gollaher, Ph.D. "The agency's commitment to a transparent regulatory process lays the foundation for ongoing process improvements."

CHI is supportive of the agency's initial recommendations, including those that will boost training for FDA reviewers and improvements that will help streamline the de novo process. At the same time, CHI appreciates that the agency acknowledges the controversial nature of a number of recommendations opposed by CHI, such as the creation of a new category of devices known as Class IIb and restrictions on predicates, and that the agency has requested further review by the Institutes of Medicine.

The 510(k) process is the clearance mechanism by which the vast majority of such medical technologies are brought to market. Each year, approximately 3,000 new devices are cleared under the 510(k) process. It is a long-standing, proven mechanism that allows medical device developers to bring new products to market based on data on existing devices, known as predicates that have already been proven safe and effective.

"We look forward to working with the agency and its new leadership to ensure that the 510(k) review process is strengthened to improve the predictability, reliability and efficiency of our regulatory pathways," Gollaher said. "A more efficient regulatory review process can stimulate investment in promising new medical technologies, which provides the foundation for delivering better treatments to patients in need."