GAO Report Could Shake Up the 510(k) Process
BY LAUREN UZDIENSKI, OCTOBER 6, 2008
The 510(k) clearance process as we know it - roughly 90 days of FDA review time and minimal data requirements - could become more burdensome in the next few years as the FDA responds to what's widely expected to be criticism of the clearance process by the GAO.
For the last several years, the GAO has been working on a report, expected to be released later this year, evaluating issues of safety and effectiveness in the 510(k) process. The study was initiated after a number of consumer advocacy groups questioned whether devices cleared under the 510(k) process were as safe as products approved under the more data-intensive PMA process. The forthcoming report is expected to come out against current 510(k) procedures and make recommendations that could slow down the clearance process and raise the evidence bar for companies. Approximately 90% of medical devices on the market are cleared through a 510(k), so much of the device industry would be affected by any changes to the 510(k) procedure.
One of the biggest potential issues for orthopedic devicemakers is upclassification. Right now, moderate-risk class-II products can be cleared with a 510(k). There is some concern that the GAO will recommend dividing class II, with devices on the more-risky end reclassified as class III. Class III devices require a PMA submission.
There could also be increased 510(k) requirements. Submissions could require additional clinical studies as well as more extensive safety testing in labs and in animals. There could also be more performance-driven data requirements and additional post-market obligations. Criteria for demonstrating substantial equivalence could become more restrictive.
If these changes go into effect, it will take devicemakers longer to bring products to market. Companies will have to be prepared to fund more extensive studies as well as plan for delays and long review times.
FDA joins industry in their concern about augmenting the 510(k) process and maintains the agency's capacity to determine the safety and effectiveness of a device under current 510(k) regulations. The agency will argue that the 510(k) is flexible enough to require more data if they feel it's needed and will probably allude to the additional resource burdens of increased PMA submissions - PMAs take about four times longer to process than 510(k)s, and some estimates say they cost the FDA 40 times what a 510(k) costs to process.
Regardless of the GAO report, the orthopedics industry has, over the past few years, seen a trend toward more robust clinical data that will continue to gain momentum. Though an increased time-to-market at the hands of the FDA could bring challenges, the benefit is that amassing stronger data could help companies differentiate their products and drive adoption.
