How to Choose the Right FDA Regulatory Pathway for your Device

Most medical device professionals and companies are familiar with Premarket Approval (PMA) and 510(k) options. However, there are several other major regulatory pathways along with several sub-pathways (traditional, abbreviated, special, and safety and performance) that are available through the FDA.

Today’s guest is Mike Drues of Vascular Sciences. Together, we introduce all of FDA’s regulatory pathways to bring a medical device to the U.S. market to help you understand which option is best for you.

Some of the highlights of the show include:

- Pathways to Market: Why are they important? Without knowing all the options, it’s difficult to choose the best regulatory pathway for a medical device.
- Which pathways are appropriate for a medical device? Depends on classification and risk, which are contingent on labeling, intended use, and technology.
- Medical Device Pyramid: Which devices are regulated by FDA, and how are they classified? Class I, II, and III. Class 0 wellness devices are not FDA regulated.
- De Novo: Alternative to 510(k) and appropriate for Class I/II Non-Exempt devices. However, De Novo is for new/novel devices without identified predicate.
- Product Development Protocol (PDP): Uncommon pathway to market due to lack of guidance and regulation. Opportunity to not conform and forge your own way.
- Humanitarian Device Exemption (HDE): PMA alternative and requirements include treating 8,000 or fewer patients per year. Most, not all, medical devices must be shown as safe and effective. HDE has no efficacy requirements.
- Custom Device Exemption (CDE): Least common pathway with potential to be the most popular pathway to market due to personalized medicine (3-D printing).
- Expedited Access Program (EAP) for Emergency/Compassionate Use: Ethical considerations because people are treated like guinea pigs, but an option to obtain early feasibility data and labeling.