How to Choose the Right FDA Regulatory Pathway for your Device

February 26, 2020

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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, he and Jon Speer introduce all of FDA’s regulatory pathways to bring a medical device to the U.S. market to help listeners decide which option is the best for them.




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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). 

  • Expanded 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.




De Novo

Humanitarian Device Exemption (HDE) 

Premarket Approval Application (PMA)

Premarket Notification 510(k)

Product Development Protocol (PDP) 

Custom Device Exemption (CDE)

Expanded Access Program (EAP) for Emergency/Compassionate Use

Safer Technologies Program (STeP) for Medical Devices Guidance Document

Webinar - Safer Technologies Program: Draft Guidance (Nov. 6, 2019)

Webinar - Safety and Performance Based Pathway Performance Criteria (Nov. 7, 2019)

Breakthrough Designation Program: Is this an option for my medical device?

Breakthrough Devices Program (BDP)

Orphan Drug Program

FDA - Medical Devices

Mike Drues

7 FDA Pathways to Bring your Medical Device to Market

MedTech True Quality Stories Podcast

Greenlight Guru True Quality Roadshow

Greenlight Guru YouTube Channel

Greenlight Guru


Memorable Quotes from this episode:

“There are seven major pathways to bring a medical device onto the market here in the United States.” Mike Drues

“Unless somebody knows all of their options, and the advantages and disadvantages to each, then how can you possibly choose the best pathway?” Mike Drues

“You cannot separate the labeling and the technology. They go hand in hand when it comes to determining your classification and risk.” Mike Drues

“(PDP) is a very, very uncommon pathway to market, but I love to use the less common pathways to market, especially when there’s not a lot of guidance or regulation.” Mike Drues



The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Like this episode? Subscribe today on iTunes or Spotify.

Nick Tippmann is an experienced marketing professional lauded by colleagues, peers, and medical device professionals alike for his strategic contributions to Greenlight Guru from the time of the company’s inception. Previous to Greenlight Guru, he co-founded and led a media and event production company that was later...

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