CHI submits comments to FDA CDRH 510(k) Working Group Preliminary Report and Recommendations

CHI- California Healthcare Institute today submitted formal comments to the U.S. Food and Drug Administration (FDA) regarding the Center for Devices and Radiological Health 510(k) Working Group Preliminary Report and Recommendations, which could transform the 510(k) regulatory process for new medical devices, greatly affecting innovation and public health in California. CHI is a non-profit public policy research organization, representing leading California academic institutions, biotechnology, medical device, diagnostics and pharmaceutical firms.

“CHI represents the entire continuum of biomedical innovation in California, including our state's research universities, industry leaders, and entrepreneurial start-up firms. In fact, the vast majority of the medical technology companies in California are smaller, venture capital-backed firms with fewer than 50 employees”

The comments, submitted to the FDA's Center for Devices and Radiological Health (CDRH), come in advance of CDRH Director Dr. Jeffrey Shuren's scheduled town hall meeting in Irvine, Calif. on Oct. 7, a critical chance for industry and patients to express their ideas for regulatory reform that will promote investment, innovation and job creation in the state of California.

"CHI represents the entire continuum of biomedical innovation in California, including our state's research universities, industry leaders, and entrepreneurial start-up firms. In fact, the vast majority of the medical technology companies in California are smaller, venture capital-backed firms with fewer than 50 employees," said CHI President and Chief Executive Officer David Gollaher, Ph.D.

"We agree that regulatory improvements can and should be made to increase efficiency, predictability and consistency of the 510(k) clearance process. However, we are particularly concerned that a number of the proposals on the table may result in a slowdown in innovation, which would lead to job loss and fewer innovations for the patients who need them."

The 510(k) process is the clearance mechanism by which the vast majority of such medical technologies are brought to market. In the last year alone, 3,000 new devices were 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.

"CHI appreciates CDRH's recognition that by increasing the predictability, reliability, and efficiency of our regulatory pathways, we can help provide better treatments and diagnostics to patients more quickly, stimulate investment in and development of promising new technologies to meet critical public health needs, and increase the global market position of U.S. medical devices," Gollaher said.

"Orange County alone is home to 29,000 biomedical jobs that pay an average of $2.2 billion in wages and salaries per year with an average wage of $76,800. Investment in these employers will decrease if there is not a clear path to market, ensuring return on investment, which will lead to job loss," said Mathew Jenusaitis, president and CEO, OCTANe, a group that connects people, capital and technology for Orange County's information technology and biomedical industries. "We are looking forward to partnering with CHI and its members on working with FDA and Congress so that these vital technologies reach patients and their physicians without a cumbersome clearance process."

"As an innovator company, Allergan shares the commitment to improving patient care through innovative, high quality, high value-added technologies," said Allergan CEO David Pyott. "CHI's comments reflect those values and I look forward to engaging with Dr. Shuren this week, continuing our ongoing dialogue about improving regulatory processes, which will ultimately improve patient care in the U.S."

Shuren's visit to Irvine marks the last of three CDRH Town Hall Meetings held this fiscal year. Other locations included Bloomington, Minn. and Boston. More information about Shuren's visit is available on the FDA website, at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm215113.htm

In addition to filing its comments, CHI joined with LifeScience Alley, the Medical Imaging and Technology Alliance (MITA) and the Medical Device Manufacturers Association (MDMA) to submit a complementary set of points. This joint effort recognizes the importance of the 510(k) system to the future of medical technology innovation across the country.

SOURCE California Healthcare Institute