5 Tips to Help Your FDA 510(k) Submission
Jon Speer, founder of greenlight.guru, is an expert at getting medical devices to market. If you’re developing a medical device in the US, chances are your path to market involves a FDA 510(k) submission. Here are some tips he has learned over the years:
Tip #1 – Use the RTA Checklist When Putting Together Your FDA 510(k)
Tip #2 – Complete All Sterilization Validation, Biocompatibility, & Electrical Safety Testing Before Submitting Your FDA 510(k)
Tip #3 – Include All Test Protocols, Data, & Results
Tip #4 – Be as Similar as Possible to the Predicate Device
Tip #5 – Expect and Understand the FDA’s Questions
