Substantial equivalence is the key to getting your Class II medical device cleared for sale by the US Food and Drug Administration. The bulk of the documentation in your regulatory submission, called a 510(k), must demonstrate your device is "substantially equivalent" to another medical device already cleared for sale by the FDA.
So what does it mean to be substantially equivalent? In this white paper, we answer your biggest questions about substantial equivalence and its role in the FDA regulatory process, including:
- What is a predicate device?
- How does the FDA define substantial equivalence?
- How do you demonstrate substantial equivalence?
- What is a 510(k) submission?
- What happens if I fail to demonstrate my device is substantially equivalent?
Learn all this and much more in this 7-page white paper.
About the Author:
Audrey Swearingen, RAC (US): Audrey Swearingen is Director of Regulatory Affairs at Emergo's Austin, Texas headquarters. With over 20 years of experience in regulatory affairs, Audrey's areas of expertise include US FDA medical device registration, as well as European and Canadian device registration.