WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) has provided recommendations to FDA on ways to improve the clarity and consistency of the agency’s premarket review process for low- and moderate-risk medical devices, also know as “510(k).”
The recommendations were contained in extensive comments AdvaMed submitted to FDA in response to a series of questions the agency issued asking for stakeholder feedback on ways to strengthen the 510(k) process.
Among its recommendations, AdvaMed proposed that FDA:
? Ensure the content and structure of 510(k) Summaries provided by manufacturers are consistent across all device types. AdvaMed believes FDA should update its guidance about the content of the 510(k) Summary and perhaps include a template for manufacturers to complete.
? Prepare and make publicly available FDA reviewer decision summaries for all 510(k)s, not just for in vitro diagnostics as is currently done. The decision summaries would provide interested parties – including FDA reviewers, clinicians and industry – with meaningful information about the subject of the submission and the predicate devices.
? Provide guidance with a template explaining data submission requirements for products eligible for FDA’s de novo process. This process allows unique, lower-risk products for which there is no predicate to be reviewed via the 510(k) route.
“The 510(k) regulatory pathway ensures that diverse medical devices are appropriately regulated by creating a risk-based, science-driven classification system that includes a comprehensive and vigorous review of device performance and test data,” said Janet Trunzo, AdvaMed executive vice president for technology and regulatory affairs. “It is important to remember that 510(k) submissions for even simple devices may contain hundreds and in some cases thousands of pages of data demonstrating safety and effectiveness, including, where appropriate, clinical testing.”
“The 510(k) process has an enviable 30-year track record of protecting the public health while making safe and effective products and treatments available without unnecessary delays. While the basic structure of the 510(k) process is sound and has stood the test of time, there is no process that can not be improved.
“This critical regulatory program has tremendous significance in the everyday lives of our citizens but is too often misunderstood and mischaracterized. Contrary to misconceptions, the 510(k) program is not a means to allow devices on the market that are equivalent to devices from 1976 nor does it represent a ‘fast-track’ or ‘expedited‘ or ‘cursory’ product review. It is a highly flexible and efficient means to appropriately regulate today’s diverse medical technology, and is only one part of a larger regulatory framework designed to ensure the continuing safety and effectiveness of medical devices.
“AdvaMed believes it is appropriate and necessary to review programs on a routine basis to make adjustments and improvements, and FDA has made many important process improvements since the 510(k) program’s inception in 1976. We support the agency’s current review of the program and the Institute of Medicine’s independent assessment. However, we urge the agency to first provide evidence that any proposed changes are warranted before making fundamental changes to the program that may be, in part, a premature response to popular public or media misperceptions.”
AdvaMed’s 510(k) comments to FDA may be accessed here.
Contact:
Mark E. Brager
(202) 434-7244
