First-time 510(k) submitters often misjudge just how rigorous the FDA’s expectations are. Choosing a predicate device that’s not a close match, providing incomplete or misaligned performance data, and neglecting critical guidance documents are all frequent mistakes that lead to costly delays, or worse, outright rejection.
According to FDA reviewers, even small gaps in documentation can trigger Refuse to Accept (RTA) decisions. And as our panel of experts confirmed, these missteps are preventable with the right planning.
Here’s what the experts had to say:
Edwin Lindsay, Compliance Solutions:
“Choosing an inappropriate predicate device, inadequate comparison, missing or incomplete performance data, and overlooking guidance documents.”
Helene Quie, Qmed Consulting:
“Companies do not engage with the FDA early enough… If the FDA is approached, there is often a lack of knowledge of the existing guidance and how to implement it.”
Karandeep Singh Badwal, QRA Medical:
“Missing/incomplete documentation.”
Carolyn Guthrie, Helix Medical:
“Underestimating the objective evidence (test data) required to demonstrate substantial equivalence.”
Michael Chen, Rook Quality Systems:
“Not fully documenting the justification/evidence on how the device is as safe/effective, even when it’s obvious to those familiar with the tech.”
Dr. Nisha Vempalle & Adarsh Anand, RegTrac:
“The most common mistake is underestimating the level of detail and documentation required…especially predicate comparison and performance testing sections.”