Regulatory Focus™ > News Articles > Custom Parts Lead to Warning Letter for Device Manufacturer

Custom Parts Lead to Warning Letter for Device Manufacturer

Posted 09 July 2013 | By Alexander Gaffney, RAC

On a normative level, choice is good, especially in the US where the notion of economic choice is quite literally the foundation of a capitalist economy. If you're in the market for a new car, for example, it's comforting to know that you're no longer restricted to a black Ford Model "T," as were early American consumers. And if you're looking to eat lunch, the variety of options may well prove dizzying.

But the one place where choice isn't quite as welcome is at the US Food and Drug Administration (FDA), which recently sent a Warning Letter to a medical device manufacturer after the company allegedly offered a variety of options meant to customize a medical device without first seeking or receiving agency approval.

The letter, released 9 July 2013, is to Biomedix, a Bloomington, Indiana-based company that manufacturers the Selec-3 Intravenous (IV) Administration Set. The product was originally cleared through FDA's 510(k) premarket notification pathway in 1993, having been found to be substantially equivalent to other IV administration sets.

But during a February and March 2013 inspection of the company's facility, FDA inspectors found a number of violations that caused the device to become adulterated and misbranded.

The problem, FDA explained in its Warning Letter, is that Biomedix "has modified the Selec-3 Intravenous (IV) Administration Sets originally cleared under K901949, K925645 and K961928 by providing customers with an ordering system to alter the device through various options and configurations." For example, customers could order different lengths of IV tubing, an optional vented spike, optional luer activated y-sites, and optional needleless luer y-sites, FDA said.

And while customization is often in the interests of consumers, and particularly those with unique needs, such customization is not without risks for medical devices. FDA explained that, "Depending on the configuration of the new components and customization, the functionality of the device can change beyond what was 510(k) cleared."

"These combinations of features can alter the performance of the device and require a new 510(k) submission," it added.

As a result, the company would have been required to have an approved investigational device exemption (IDE) under section 510(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act), or an approved application under section 510(k) or 515(a), also known as premarket approval (PMA). Accordingly, the devices were found to be misbranded and adulterated, and FDA said the company would need to immediately rectify the situation.


Warning Letter to Biomedix


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