Last year, the FDA reviewed the 510(k) process. As a result of its review, the FDA recently issued new draft guidance documents, including “Deciding When to Submit a 510(k) for a Change to an Existing Device.” When finalized, this new guidance will replace the existing (1997) “Deciding When” guidance. For medical device manufacturers, the new guidance means a couple of major changes, including a new section on how to evaluate manufacturing changes to your 510(k) device.
Based on this new guidance, manufacturers should reevaluate the process by which they determine whether a change to a 510(k) device requires a new 510(k) application. For example, the new guidance clarifies that although an individual change may not require a new 510(k), that same change taken as a whole with contemporaneous or subsequent changes could be sufficient to require a new 510(k). Thus, manufacturers must examine the totality of all changes from their last 510(k) to present to determine whether a new 510(k) is required. To assist a manufacturer in making this decision, the manufacturer is directed to answer a series of questions.
Another important distinction is that the new guidance also states that manufacturers must consider whether a change to their manufacturing process itself constitutes a change in the 510(k) device. If the manufacturing process was part of the original 510(k), a change in the manufacturing process could in fact mean that a new 510(k) is needed.
Failure to follow the new guidance and to understand its implications could result in additional product liability suits against manufacturers. In defending product liability suits, manufacturers often rely on 510(k) compliance as part of their defense. Thus, staying abreast of the new guidance and following its directives could become critical in future litigation. Failure to abide by the new guidance could expose a manufacturer to greater liability in future product liability suits.
Finally, it is interesting to note that many of the changes in the new guidance could force courts to revisit the issue of whether preemption should apply to 510(k) devices. The Supreme Court recently tackled this issue in Riegel v. Medtronic, Inc. Holding that 510(k) devices did not enjoy the same preemption from common law suits as pre-market approvals (PMAs), the Court based its reasoning on the fact that the prior 510(k) process was unrelated to the safety aspects of the device. The changes in the new guidance appear to have a much more safety-oriented theme. Once the new guidance is finalized, one could argue that by eliminating the substantial equivalence process and replacing it with a more safety oriented process, 510(k) devices should now enjoy the same preemption protection that PMAs do.