Sciessent Medical Blog

Everything You Ever Wanted to Know about the FDA’s 510(k) Submission … But Were Too Afraid to Ask (Part Three)

Posted by Administrator on Apr 19 2016

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We’ve come to the end of our blog series about best practices for the FDA’s 510(k) submission process for antimicrobials. We discussed the importance of defining the indications of use, choosing predicate devices and defining antimicrobial chemistry and mechanism of action. Today, we’ll look at three more areas that will help med-device manufactures realize regulatory success.

Explaining release mechanism and kinetics: For this category, the FDA is looking to understand how the antimicrobial is released from your device. The release mechanism is very detailed and scientific and your antimicrobial partner should be able to provide you with that information. When it comes to release kinetics, the FDA requires you to demonstrate how the antimicrobial is released from your device. The nation’s top antimicrobial technology vendors often provide the use of their own labs for kinetic testing (and will work closely with clients to develop the most appropriate testing methodologies).

Sharing antimicrobial concentration: The FDA will want to know, specifically, the concentration of the antimicrobial within the device, as well as the minimum effective concentration, in order to evaluate safety and efficacy.

Documenting distribution kinetics, toxicity, metabolites and degradation: If the antimicrobial is an eluting technology, you’ll have to describe the distribution kinetics (how the antimicrobial is distributed throughout the body once released), toxicity (the level when the antimicrobial becomes toxic) and metabolites and degradation (how the antimicrobial interacts with cells and processes in the body). If not, you’ll have to prove that nothing is eluting into the body.

To read more about these tips for 510(k) submission success, download “An Essential Guide to Navigating the FDA’s 510(k) Requirements.”

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Topics: 510(k), medical device, HAIs, healthcare