The process of submitting a 510(k), demonstrating that your device is substantially equivalent to a device that is already cleared, can be daunting. Typically designed to be a 90-day review by the FDA, the entire process could take several months if adequate information is not supplied to the FDA. Their requests for additional information need to be met satisfactorily and in full, or you risk delaying your release schedule and going into a total of three rounds of questioning. If you have not adequately addressed the FDA’s concerns after three rounds of questions, your device will be found not substantially equivalent (NSE) to the predicate device(s). Ideally, you’ll avoid rejection and an NSE letter, and your device will gain clearance into the market, keeping your release on schedule and your investors happy.

Here are 10 vital recommendations for making your 510(k) submission process run efficiently and effectively.

1. Develop an FDA submission strategy as early in the development process as possible. Often companies don’t write a strategy. They just know down the line they are going to write a 510(k) and don’t start it until testing is almost complete. Your submission strategy should include the standards you will test to, the testing you will conduct to demonstrate substantially equivalent performance, the necessary clinical trials and comparisons to your predicates. If the predicate devices or strategy is not clear-cut, obtain independent review from a regulatory firm or from FDA via the pre-submission process. There are pros and cons to using the pre-submission process which must be evaluated for each submission.’

2. Begin to write the 510(k) as soon as possible in the development process, outlining what testing and other documentation will be needed. Share this with the product development teams early and often so they know where they are required to insert information, eliminating gaps in the 510(k) deliverables upon completion of development and testing.

3. Coordinate all claims with marketing before or during product development. Marketing departments often push back on this because they are not ready to provide all marketing copy, or they feel the indications for use are adequate and additional claims are not necessary. Additional claims that are not included in the 510(k) submission may trigger a new 510(k) submission on their own. These types of claims would not be useable in marketing materials until a subsequent 510(k) clearance for those claims is received.

To read the rest of the tips, go to for the full article.

We are passionate about your success. Tell us more about your regulatory and quality needs so we can help.

Book a Consultation


To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.

Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!