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Regulatory Expert Builds Web Tool to Assist Companies with 510(k)s

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.

    Eric Eggers“I designed this as a regulatory guy struggling to find good predicates and to use my time wisely,” says Eggers, Founder and CEO of kBLASTER. “Pre-kBLASTER, I spent a lot of time digging through the FDA site.”

    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.

    “One thing that FDA’s site absolutely doesn’t do, which is a big reason that I made this site, is allow a saved search function,” says Eggers. “If you’ve found predicates that help you but you hope for something better, you can save that search. Then, every month, as new data is uploaded from the crop of predicates that are cleared and made public, if something hits your parameters, you get an automatic email and a flag notification in your account.”

    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:

    • “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.”

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    At OMTEC 2015, Constance Soves with FDA’s
    Division of Orthopedic Devices, Office of Device Evaluation, spoke on best practices for 510(k) submissions. 
    They are summarized below.

    •   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.

    •   Include the checklist in the submission and 
    indicate the page numbers where each
    respective criterion is addressed.

    •   Address each checklist criterion fully.
     -Include reasoning for alternative 
    approaches or omissions.
    -Don’t allow the reviewer to make assumptions
    about whether a criterion is applicable or not.

    •   Ensure that contact information is correct.

    •   Contact 510(k) staff immediately if you don’t
    receive a Refuse to Accept (RTA)
    status email by day 16 (first, check your junk folder)
    or if you disagree with the “not accepted” decision.

    FDA also addressed updates and changes from the
    Final Guidance for Evaluating Substantial Equivalence in Premarket Notifications, issued on July 28, 2014.
    The guidance details the Agency’s review practices for 510(k) submissions by describing the regulatory framework, policies and underlying practices. 

    To access the full presentation, FDA Advises on How to Improve Your 510(k) Submission Process, click here