Charlotte Baker is the Senior Director, Regulatory & Strategic Development, Medical Devices, at Clinipace Worldwide.

In the webinar I hosted, Streamlining the Regulatory Path to Market for Low Risk Medical Devices, we reviewed vital steps to receiving FDA clearance of Class I and II medical devices and strategies for streamlining the process. It was a particularly useful conversation for emerging or venture-backed firms new to the regulated medical device industry.

We had so many excellent questions from attendees following the webinar, so we decided to address some of those in a series of blog posts for everyone to benefit from the feedback. In the first Q&A posts, we answered some of the questions we received around clinical trial data and understanding classes.

In this post, we’re addressing questions related to the application process. If you have any additional thoughts or related questions to ask our experts, please share your comments below.

Q: What are some of the most commons pitfall or hurdles encountered in the application process?

A: If your device falls under the requirements for a 510(k) (21CFR 807), the most common issues are related to one of the following:

  • Inappropriate predicate chosen
  • Lack of or inadequate performance or safety data
  • Non-compliance to Quality System Requirements or to Good Laboratory Practices (if required)
  • Labeling

Q: What is the average time and cost for getting a medical device approved? How about a Class I?

A: It depends. The average time and cost for getting a medical device on the United States market—not necessarily approved and cleared—depends on the complexity of the device: Whether it falls into Class I, Class II or Class III.

If you look at the risk-based classification scheme the FDA has promulgated, a Class I device being low risk and a Class III device being a high risk, you can usually correlate those to the time for getting on the market and the burden of evidence needed to get on the market. In other words, for example, a Q-tip is a Class I medical device. It’s very safe, effective, and low-risk to a patient. Therefore, the burden of evidence required to get it on the United States market is very limited. Whereas a Class III device, such as a pacemaker, would have extensive clinical data and would likely take years to get on the market, especially if it was significantly different from what’s already out there.

Q: For the first application fee waiver for a small business, is there a form for that?

A: Yes, there actually is. On the FDA’s website, if you go to the small business link, there are some forms that have to be filled out in order to apply for that exemption.

If you’re interested in learning more about Streamlining the Regulatory Path to Market for Low Risk Medical Devices, be sure to listen to our webcast in its entirety. Check back soon for part four of the Q&A series as well as the related eBook.