After years of frustration using FDA’s 510(k) search function to prepare his own submissions, Eric Eggers felt there had to be a simpler, faster way. This drove him to create his own 510(k) search function called kBLASTER®, a tool designed to help medical device professionals more easily find the information they need for their 510(k) submission processes.
- “Find the absolute best primary predicate for your submission to FDA. Some people think they find a good enough one, or think that because they spent too much time on it, it must be good enough. If you say that, you’re setting yourself up for a disappointing discussion. When you submit it, FDA could totally disagree or see no merit in what you’re saying.”
- “Do your homework. Don’t go on bended knee to FDA and have them try to figure it out for you. That doesn’t work out well. They want to see you come in resolutely, understanding your position and the strengths of your position.”
- “If it’s available to you, investigate whether your type of device is applicable to the third-party review process. If you can do that, investigate who your third-party reviewer is, what kind of track record they have and the volume of cases they handle and clear. That process has worked out very well.”
kBLASTER is a Software as a Service search of all publicly-available FDA 510(k) summaries for a primary predicate, multiple predicates or reference devices. The software, launched in 2014, manages search results with several features such as sorting, bookmarking and search saving from one web browser location, allowing users to access through any of their mobile devices, tablets or computers.
Eggers, who has held regulatory roles in medical device companies (mostly startups) for over 20 years, says that proper preparation is of the upmost importance to start a smooth submission process with FDA. He offers three pieces of advice for companies submitting 510(k)s:
• Make a good first impression.
-Be organized with page numbers, headings and a
table of contents. Hyperlinks and bookmarks within eCopy help.
-Avoid data dumping. Follow the order of the checklist and make sure that all provided information
has a purpose, as too much information
may delay the process.
-Proofread to ensure consistency throughout.
Tell the story of equivalence.
• Ensure that contact information is correct.
FDA also addressed updates and changes from the
To access the full presentation, FDA Advises on How to Improve Your 510(k) Submission Process, click here.