Sciessent Medical Blog

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

Posted by Administrator on Apr 6 2016


In our last blog post, we discussed the industry-wide uncertainty around the FDA’s 510(k) submission process for antimicrobials. But it can and has been done by following some proven best practices. We touched on knowing the indications for use with an antimicrobial –knowing what your claims are and proving them – and today we’re going to talk about three more requirements.

Choosing a predicate device: Using a technology that has already gone through FDA approval gives you a predicate for use of the technology. Without that, you can’t use the 510(k) process and will have to go through a complex Premarket Approval (PMA) submission. It is common to use multiple predicate devices for antimicrobial products – with the existing non-antimicrobial product itself acting as the primary predicate device. Once you have that, you need a predicate for the use of the antimicrobial technology. In this case, using a split predicate is recommended.

Describing the antimicrobial chemistry: The FDA expects a detailed, clear description of the antimicrobial chemistry. This is often a challenge for manufacturers – skilled in the world of mechanical engineering, but not fluent in the world of chemistry. This is when working with an experienced antimicrobial supplier can come in handy – especially if it can provide these descriptions for you.

Defining mechanism of action: For this aspect of the 510(k) submission, the FDA wants to know two things: how the antimicrobial kills and what it kills. If the antimicrobial technology is new, it is critical to make sure your antimicrobial partner has data to support how it works.

To learn more about these requirements, download “An Essential Guide to Navigating the FDA’s 510(k) Requirements.” below.. In our next post, we’ll discuss release mechanism and kinetics, antimicrobial concentration and toxicity, metabolites and degradation.

Get The Free Article

Topics: Antimicrobials, 510(k), HAIs, medical devices