Aug 1, 2011

A long-awaited report issued July 27 by the Institute of Medicine of the National Academies (IOM) has recommended that the US Food and Drug Administration (FDA) replace its current 510(k) program for Class II medical device reviews with a new process that does not rely on substantial equivalence for clearance decisions.

The FDA commissioned the IOM in 2009 to examine whether the 510(k) process adequately protects public safety and promotes product innovation, and if not, which regulatory and legislative efforts would be needed to improve the clearance process. The IOM recommendations were sought as part of the FDA’s broader Plan of Action for Implementation of 510(k) and Science Recommendations, a set of 25 action items for improving medical device review processes to be implemented in 2011.

While IOM recommendations have often been taken quite seriously by the FDA in the past, it should be emphasized that the regulator faces no legal obligation to implement any of the IOM’s recommendations concerning the 510(k) program. Given the FDA’s limited administrative resources as well as ongoing US Congressional scrutiny of FDA review practices prompted in part by industry lobbying efforts, it’s highly doubtful that the agency will act upon the IOM report in the near term.

In its report, the IOM concluded from its investigation that the 510(k) process cannot properly determine safety and effectiveness of Class II devices as long as the program’s key criterion for clearance is based on Substantial Equivalence to one or more predicate devices. Furthermore, insufficient available data make it impossible to determine whether the 510(k) process supports or hinders product innovation, according to the IOM.

Specifically, the IOM recommends scrapping the 510(k) program in favor of a new clearance process with eight high-level characteristics:

  1. The current 510(k) program should be replaced by a regulatory framework with integrated pre- and post-market capabilities, 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.

Again, although the IOM report was highly anticipated as part of the FDA’s broader effort to reform the 510(k) program, the organization’s recommendations appear to go further than what the agency had perhaps expected. As such, swift implementation of what the IOM has suggested remains unlikely, at least in the short term.


  • Stewart Eisenhart