When I learned about the regulatory process that a medical device goes through to get to market, I learned about it on-the-job from experienced medical device communications colleagues, clients and their regulatory counsel. Since then, I’ve looked for resources to pass on to other teammates or students to explain the process, which can be complex. I’ve found some really good descriptions of the process a drug or biologic undergoes (one of my favorites is by my colleague Mark Senak), but nothing that really works for medical devices. (If you have a resource, please share it!)
So, here’s what I’ve developed and shared (with the caveat that I am not a regulatory expert. I have a lot of experience with FDA-regulated products, and I’m offering this from a communications perspective.)
Devices are can go through two different processes at the FDA: The 510(k) and the Premarket Approval (PMA). Every year the FDA reviews thousands of 510(k) submissions, which is about 10 times as many PMA applications.
Approximately 90% of device applications that the FDA receives annually go through the 510(k) process. This is a premarketing submission made to the FDA to demonstrate that the device to be marketed is as safe and effective (substantially equivalent) as a device that is already being legally marketed. This process on average takes under five months, although it can range from three months to about a year. Because it usually requires no clinical trials or research it also requires less investment and presents less financial risk to investors.
However, changes are underway. The FDA is now requiring some devices going through the 510(k) process to have supporting clinical data, requiring a trial. This is generally the case when there is a new technology or a request for a new indication for use. When a study is required, it is the same as an IDE study (explained below).
A PMA is an extensive application submitted to the FDA to request approval to market. Unlike a 510(k), a PMA is based on the FDA’s determination that “there is sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use or uses.” (http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm)
This process generally takes at least five years, and often longer. Here’s the process at a glance:
- Feasibility studies are usually animal studies, and may include other kinds of economic and market research.
- Investigational Device Exemption (IDE) approval is required from the FDA before in-human trials can begin. An IDE trial can be a small, pilot or proof of concept study, or it could be a large pivotal trial.
- In the medical device world, a pivotal trial is considered large when it includes several hundred patients, vs. the several thousand that may be included in a trial for a drug or biologic.
- All PMAs for a first-of-its kind-device require an advisory committee review. (I’ve never worked on a project going through the PMA process that didn’t have an advisory committee meeting.)
- Of the three decisions the FDA can make, two are clear-cut: The device is approved or not approved. An approvable letter is a lot less clear-cut. It means that the review is complete, but the FDA wants the company to address a few things, such as labeling, or setting up an inspection. When the issues are addressed to the FDA’s satisfaction, then the device may be approved.
- The FDA clears 510(k) submissions and products receive 510(k) clearance.
- The FDA approves PMA applications and products receive FDA approval.
Other Good Resources
This information reflects my experience in working with FDA-regulated products. Please only use this is a guide, and if you need the final word on matters, talk to your regulatory expert!
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