FDA’s Review of the 510(k) Process

The FDA is charged with promoting and protecting the public health.  The promotion part is viewed as fostering innovation to address unmet clinical needs for disease diagnosis or treatment.  The protection part is to ensure that products on the market are safe and that money isn’t wasted on ineffective products.  In regard to medical devices, the FDA has said it has three key objectives to support its overall mission:  foster innovation, enhance device safety and create a predictable regulatory environment.  The 510(k) pathway is how most devices enter the market and the FDA has been criticized both for allowing unsafe and ineffective devices to be used and for increasing the cost and time to develop products by creating uncertainty in the process.  The FDA conducted a review of the 510(k) process and released two preliminary reports with recommendations for reform.   (FDA Reports)

One of the reports focused on the 510(k) process and one on the use of science by the FDA.  Both contain a number of recommendations.  The most significant relate to clarifying the situations in which predicate devices can be used and how substantial equivalence is demonstrated; and creating a new sub-category for devices which don’t have predicates but don’t present substantial safety risks.   More precisely describing the situations in which multiple predicates may be used was recommended, as was eliminating the use of split predicates.  Ensuring that the agency has adequate access to all relevant information is another focus.

The biggest concern industry likely has with the recommendations for changes is the possibility that it will be harder to use predicate devices to support a 510(k) and that more devices may need to be supported with clinical evidence, which is expensive and time-consuming to accumulate.  While the report suggests FDA head in this direction, it also clearly recommends that FDA create much more clarity in exactly what data is needed for approval and that it minimize collection of clinical data to that which is really necessary.  The industry’s concerns are understandable, but maintaining a very high level of public confidence in medical devices is also important to the sustainability of growth.  Having only safe and effective products on the market is in everyone’s interest.