Authored by Innovative Science Solutions, now part of Lumanity

Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare markets in the world.

The 510k medical device regulatory pathway is typically the most economical and fastest path to approval. In addition to the typical application information, the 510k requires a summary of the scientific data to support the device, as well as a comparison to a predicate device. Medical devices that are successful in foreign markets on the merit of their scientific evidence are obvious candidates for introduction into a US market. The 510k pathway allows foreign manufacturers to submit a summary of this data to the FDA, who can then approve their device for sale in the US market.

The 510k’s Section 12: Substantial Equivalence Discussion, where the predicate device(s) is/are selected, tends to be the most technically and scientifically challenging aspect of a submission for ex-US approved medical devices. While ex-US manufacturers are familiar with their own markets and competitors, they must select a US-approved device(s) that is most similar to their device in a number of different aspects. The purpose of the “predicate device” section of a 510k application is to convince the FDA that there is precedent for the safety and efficacy of the new device, such that a more extensive premarket notification or de novo application would not be required.

The FDA has outlined their thought processes for the most compelling 510k predicate device selection and justification. After helping many foreign companies with 510k submissions, we recommend reading this guidance thoroughly to gain a baseline understanding of the necessary considerations for developing a predicate device section.

In addition to these fundamental requirements, which should only be considered as the minimum that should be considered when pursuing a 510k pathway, there are several other strategies we have found that have helped improve the success of a 510k submission:

Inclusion of foreign predicate devices

  • While the FDA requires selection of a US-approved predicate device, we have found that including additional descriptions of foreign predicate devices can help bolster support for the application. The fundamental purpose of the comparison of your device to a predicate device is to convince the FDA of “the principles of safety and effectiveness [that] underlie the substantial equivalence determination” We have found that research identifying multiple foreign medical device equivalents, while not required, helps contribute to the strength of the argument that the new device is safe and effective

Inclusion of multiple US predicate devices for devices with unique characteristics

  • We recommend that a sponsor consider including summaries of multiple medical devices when the applicant device has unique aspects that may deviate significantly from any individual US-approved product. When including multiple devices in a 510k application, you should develop detailed summaries that describe well supported comparisons between the new device and every predicate device selected for inclusion in the application
  • For example, suppose you have an adhesive bandage that includes a color-changing coating responsive to skin temperature changes. Upon review of the FDA predicate device database, you initially search bandages, but can find no approved bandages that include a temperature probe. The next step would be to find an approved temperature probe similar to the one on your bandage. The predicate device section of your 510k application should then describe how your device is similar to the bandage, similar to the temperature probe, and then include a scientifically justified explanation of how the combination of both would not introduce any new safety or efficacy issues.

Lumanity has identified the tips described in this post as crucial to success when developing the predicate device section in a 510k submission. Researching compelling predicate device data and creating a strong scientific narrative is crucial for 510k success. A rejected 510k submission means a sponsor must resort to the significantly more costly premarket notification or de novo pathways. We have assisted dozens of clients and our expertise and experience can help you achieve success. Contact us today if you are considering a 510k submission.