Do you know how to use the FDA’s abbreviated 510(k)? Since only 2 percent of 510(k)s have gone the abbreviated path, it’s likely an accurate assumption that many don’t know how to use it.
Today, Mike Drues, the president of Vascular Sciences, and Jon Speer are going to delve into the abbreviated 510(k) path and how it can benefit you.
Some of the highlights of the show include:
● The three principal types of 510(k)s and how they differ from one another.
● The crux of the abbreviated 510(k) and how the documentation of substantial equivalence differs from how it’s done for the other types.
● The most current statistics on how much the abbreviated 510(k) is used and Mike’s thoughts on why the number has dropped.
● The review times for the abbreviated vs. the traditional 510(k).
● Information on the format and content of the abbreviated 510(k).
● Why it’s important to show why the consensus standards are applicable even though the regulation doesn’t require it.
● Why many 510(k) submissions are rejected.
● What’s happening on a regulatory perspective in other parts of the world as well as Mike’s thoughts on alternatives to the 510(k).
● The importance of thinking outside the box when it comes to regulatory matters.
● Mike’s best advice for those preparing to submit their documentation: Be aware of all of your options and the advantages and disadvantages of each.
Links and Resources:
Quotes by Mike:
“I pride myself on thinking outside the regulatory box.”
“A very small number of the 510(k)s are brought to market as an abbreviated 510(k)... Just because something is seldom used doesn’t mean that it doesn’t have significant advantages.”
“Abbreviated might not mean what you think it means. It does not mean less time or less work.”
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