Sciessent Medical Blog

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

Posted by Administrator on Mar 23 2016

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At Sciessent, we work heavily within the healthcare space – helping manufacturers bring their antimicrobial-treated devices to market. Not only do we provide the antimicrobial technologies, but we’re also very involved throughout the lifecycle of the product – from design, development and testing to FDA approval. While some antimicrobial vendors simply provide the technology and bolt, we act as a partner for our customers because, without mincing words, there is a lot of uncertainty and confusion out there about bringing an antimicrobial-treated product to market.

The majority of this uncertainty and confusion is around the FDA’s 510(k) requirements for antimicrobial devices. In 2007, the FDA released draft guidance for 510(k) submissions, but there is no indication that formal guidelines will be released any time soon (if ever). Navigating the regulatory pathway has actually stopped some med-device manufacturers from pursuing plans for antimicrobial-treated products.  

Lise Moloney, Sciessent’s director of business, healthcare, is one of the top experts on the FDA’s 510(k) requirements and has worked closely with countless customers to guide their antimicrobial-treated products through to approval. Given the many unknowns, Lise created a resource guide about what the FDA is looking for in 510(k) submissions.

In “An Essential Guide to Navigating the FDA’s 510(k) Requirements”, Lise identifies the top seven most important areas specific to antimicrobials that the FDA has indicated it’s looking for in a 510(k) submission – and you, your regulatory team and your antimicrobial partner should know them back and forth.

The first requirement is around indications for use. This means knowing what your claims are around the antimicrobial – and proving them. While this might seem straightforward, manufacturers hit road bumps when there are disconnects between marketing and R&D. Often, marketing will want to claim the antimicrobial can do certain things that R&D never tested for. Lise urges med-device manufacturers to discuss and define indications for use upfront because, if they claim a product is going to do X, Y and Z, then it must be tested for X, Y and Z before a 510(k) submission can happen.  

To read more about the what the FDA expects in a 510(k) submission, you can download “An Essential Guide to Navigating the FDA’s 510(k) Requirements” here. In our next post, we’ll discuss three more areas, including predicate devices, antimicrobial chemistry and mechanism of action.

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