A highly anticipated report by the Institute of Medicine of the National Academies (IOM) has found the US Food and Drug Administration’s 510(k) clearance process fundamentally flawed, arguing that the agency has focused on substantial equivalence at the expense of safety and effectiveness when it comes to evaluating Class II devices.

Rather than suggesting improvements to the 510(k) process, the IOM report recommends replacing it altogether with a new review process for Class II devices that does not rely on substantial equivalence as a requirement. Although the FDA has taken seriously IOM recommendations in the past, the agency is under no obligation to act upon the 510(k) report—and likely will not in the short term, given its limited administrative resources as well as the sheer weight of the recommendation itself.

As the FDA began considering changes to its 510(k) process, the agency tasked the IOM in 2009 with examining whether the existing clearance process protects patient safety and promotes innovation, and if not, recommending possible regulatory and legislative avenues to better achieve those goals.

Following its evaluation of the 510(k) program’s history, implementation, context within the FDA’s larger medical device regulatory framework and other factors, the IOM concluded that the 510(k) process in its current form cannot effectively determine safety and effectiveness as long as its key criterion for clearance is substantial equivalence to one or more predicate devices. In addition, the IOM concluded that insufficient data exists to determine whether the 510(k) process supports or inhibits product innovation.

The IOM report provides eight recommendations not for improving the 510(k) process, but for scrapping it altogether in favor of a new regulatory framework for reviewing Class II devices.

1. The current 510(k) program should be replaced by a regulatory framework with integrated pre- and post-market capabilities, and focused on providing reasonable assurance of safety and effectiveness rather than proof of substantial equivalence.
2. The FDA should develop and implement a new strategy to collect and analyze post-market surveillance data to improve short- and long-term oversight of medical device safety and effectiveness.
3. The FDA should identify limitations to its post-market regulatory authority to improve handling of device recalls and corrective actions.
4. Instead of the 510(k) program, the FDA should examine whether a modified version of its current de novo process for down-classifying lower-risk devices can be used to review Class II products.
5. A quality assurance program should be established by the FDA in order to track regulatory decisions, identify process improvements and tackle emerging regulatory issues.
6. The agency should commission an investigation into how its Class II clearance process affects medical device industry innovation.
7. More substantive procedures should be put in place to ensure safety and effectiveness of software used in conjunction with medical devices, and updated guidance on software validation should be developed.
8. The FDA should either order pre-market assessments for or reclassify the 26 Class III device types still eligible for 510(k) clearance—a process the agency has had 35 years to complete.

"We're suggesting a paradigm shift that will be disquieting to a variety of constituencies," Dr. David Challoner, chairman of the IOM's Committee on the Publich Health Effectiveness of the FDA 510(k) Clearance Process, said during a July 29 public hearing on the report's findings. Indeed--but to what extent, if any, will the FDA adopt that suggestion as policy?