US regulators regularly send letters to industry regarding alleged transgressions, deficiencies and faults. The most common ones are well-known to the industry: Form 483s outline deficiencies found during inspections; Warning Letters highlight major deficiencies and threaten action; and Untitled Letters highlight potential issues. But this week the US Food and Drug Administration (FDA) revealed that it had sent off another type of letter to a medical device company, one rarely publicized by the agency.
The letter, sent at an undetermined date, is known as an "It Has Come to Our Attention Letter," which has rarely been publicized-or perhaps even used-by the agency in its recent history.
The letter is so named due to its starting sentence and the topic of discussion. In the case of Biosense Technologies, FDA wrote that "It has come to our attention" that the company is currently marketing its uChek Urine analyzer, a device compatible with several types of reagent strips manufactured by Siemens and Bayer.
The device is meant to work with Apple products such as the iPhone, allowing the iPhone camera to read test strips and analyze their contents.
The intent of the device, FDA wrote, is to provide a quantitative and "semi-quantitative" assessment of urine analytes, including glucode, ketone, blood, bilirubin and leukocytes, making it a medical device under FDA's interpretation of the law.
"The uChek Urine analyzer appears to meet the definition of a device as that term is defined in section 201(h) of the Federal Food Drug and Cosmetic Act," FDA clarified. And that could be a problematic determination for Biosense, as the company does not have an approved 510(k) premarket notification or premarket approval from FDA.
While the strips themselves are cleared under FDA's 510(k) pathway, FDA notes that an essential part of their clearance is the method of interpretation. As the uChek was not part of Siemens' and Bayers' clearance applications for their respective testing strips, this would require Biosense to obtain new clearance to market the devices, FDA stated.
Part of a 'Triage' Strategy
What's clear from the letter is that, unlike a warning letter or untitled letter, FDA does not seem to be on as sure footing as it would otherwise like to be. The agency writes that if Biosense does not believe that it is required to obtain FDA clearance for its device, then it may provide FDA "with the basis for that determination" within 30 days of receipt of the letter.
The letter is one of only a handful of such letters disclosed by the agency in recent years. In 2010, the agency, acting under the direction of Alberto Gutierrez, director of the Office of In Vitro Diagnostics, sent several "It has come to our Attention" letters to another direct-to-consumer (DTC) testing agency, this one associated with do-it-yourself genetic tests.
The only other public mention of a similar letter is referenced in an October 2011 Warning Letter to SteriMed referencing an adulterated femoral product.
Prior FDA explanations make clear that the letters are part of a "triage" strategy practiced by the agency's device regulators in which the "It Has Come To Our Attention" letter follows a "call to clarify," preceding further actions such as an Untitled Letter, Inspection or Warning Letter.
FDA's Letter to Biosense
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