You and your regulatory and technical team think the regulatory path for your medical device should either be exemption from the market approval or, at most, a Premarket Notification (510k). Even though you are confronted with both exempt and 510k-cleared devices that are similar in technology and concept to yours, there is no clear-cut predicate. You are now faced with the dilemma of which regulatory path to choose.

In this situation, an FDA determination of exemption from the market approval is most desirable but highly unlikely if the FDA has found similar devices to be Class II, that is, devices involving moderate risk, which must be cleared through a 510k. In any case, you would want to avoid the FDA’s most costly and time-consuming pathway of Premarket Market Approval (PMA).

This situation often presents itself in the case of medical software that is used as a reference tool to assist in diagnosis. Some may argue that software is not even a device in the same category as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other related article. How, you might wonder, can software that is only used as a reference tool, analogous to medical texts, online databases, and journals, be perceived to be a medical device under the FDA regulation when it does not diagnose, cure, mitigate, treat, or prevent a disease or affect the structure or function of the body? In such a situation, you might choose among the following pathways:

  1. Market the device without involving the FDA based on the idea that the software is beyond the FDA’s jurisdiction because it does not meet the FDA’s definition of a medical device.
  2. Seek a Class I designation from the FDA for the device, making it exempt from any market approval.
  3. File a 510k application.
  4. Seek the FDA’s guidance on the classification of the device, predicate selection, type of tests and studies to be conducted, indications of use, etc. to make sure the FDA’s thinking is aligned with yours.

Even though the first approach will be the least expensive, we have rarely seen it succeed. Such an approach often results in a warning letter from the FDA finding the device to be misbranded and its marketing to be unauthorized. The third approach will be the most risky because, after expending significant time and expense on a 510k application, you may be slapped with a determination of not substantially equivalent (NSE) from the FDA, meaning that the FDA finds the device to be in the most-risky category, requiring a PMA.

If you have sufficient time, the last approach will be the least risky, because if you know that the FDA is likely to be inclined toward a PMA, you can try t o rationalize a 510k approach, or even seek a de novo classification, which is intended to apply to low-risk products that have been classified as Class III because they were found NSE to any identifiable predicate device.

Determining whether to seek informal guidance from the FDA or to request a pre-IDE meeting with the FDA is critical to this process. For a discussion on the many pitfalls of pre-IDE meetings, stay tuned for our next post on this topic.