The Four Routes to FDA Approval, and How to Choose

medical devices and instruments on a table

Part I of a two-part series. Read Part II: How Complicated Can an FDA Clearance Get?

Navigating the Food and Drug Administration (FDA) approval process for medical device manufacturers can be a bit like doing your own taxes. It’s often more difficult than it appears, unless you’re a pro at it. And even then, things change every year. (In fact, FDA device reviewers have an average career-span of about five years before they go outside and consult.)

In the case of FDA clearance advice for medical devices, it's difficult to make broad generalizations about the application process, or about conducting a clinical trial process. Nearly every situation is unique and every device application is evaluated one at a time. Nevertheless, you’ll find some helpful information here.

Although broad characterizations about the process itself may not work, there’s a lot of room for determining which regulation defines your device. However, the regulation may only be one or two paragraphs—and say nothing about the need for a clinical study, or the type of application needed, where to send applications, or other useful tips. According to FDA policy analyst, Zane Wyatt, “Helping people figure out the initial bureaucracy involved in getting your materials to the right people is the biggest initial hurdle.”

“Helping people figure out the initial bureaucracy involved in getting your materials to the right people is the biggest initial hurdle.”

Zane Wyatt, FDA Policy Analyst

In addition to his role as policy analyst, Zane helps educate companies about the FDA process and how to navigate the system. He teaches about the different submission types, the kind of material required for a pre-submission, and so on. Instruction can be more of an overview, covering all of the various programs, pathways and device type areas, or focus a specific route for a particular device.

Should the company decide it wants to submit an official application to the FDA, the educator would then be recused from the process.

The Path to Yes

Wyatt explains the three main paths that device companies take to FDA approval, as well as a fourth path that may be advantageous yet little-known.

  1. Do It Yourself — DIY types are usually smaller companies that look at what the process costs, then decide to go it alone and try to teach themselves.
  2. Get your own Regulatory Affairs Department — Obviously, these are larger companies with in-house attorneys and former FDA employees and regulatory staff that do the work for them. The really big medical conglomerates have whole departments devoted to regulatory affairs.
  3. Hire a consulting firm — There are large consulting firms that will essentially allow a company to focus on just the technological innovation while they handle everything else. Such consultants are very good at arguing with the FDA and will get you a clearance and an approval. While they excel at influencing and pressuring and collecting the right data, they're also extremely expensive. Unless you’re well-funded, this option may be off the table.
  4. Find an FDA educator — These are FDA employees who obtain a clearance to work as educators outside their government capacity in order to help companies determine the best possible path for a specific device. Educators are not consultants and are not responsible for any specific submissions.

Where Does the Approval Path Start?

The FDA publishes a lot of resource material, but it’s not so easy to navigate. According to Zane, “A lot of my job is actually sending links to all the various resources that have been published online, depending on the situation. And then if there's anything in that document they don't understand, I can help explain.”

When asked to share one of the more popular FDA links, Zane recommends “CDRH Device Advice,” the FDA’s Center for Devices and Radiological Health (CDHR) web page for comprehensive regulatory information. “That's the biggest repository where everybody should start to figure out how they need to go about marketing a medical device,” he says.

Are We There Yet?

To find out how long the FDA approval process could take, what could shorten it, and how complicated things could get (even based on your choice of wording), be sure to read Part 2 of our series: “How Complicated Can an FDA Clearance Get?”

In the meantime, learn more about how to demystify the FDA by visiting Axis Research & Technologies. See the Online Courses and Consulting page for Regulatory Affairs education and resources.

About Axis

Axis Research & Technologies provides simulated medical environments for use in the training of surgical procedures and development of advanced medical devices. We work with medical device companies, institutions, and medical professionals. Our medical skills training platform uses Mixed Medical Reality, Augmented Reality and Artificial Intelligence. To learn more about Axis, visit our website at axisrt.com.