The latest mobile medical application news on the industry's collective mind is the issuance of an "It has come to our attention..." letter sent to Biosense Technologies in India, essentially questioning why Biosense has not obtained 510(k) clearance for their uChek mobile application. The device is a mobile medical application for phones that takes a picture of urinalysis strips and compares the color against a standard to make a determination about the status of a patients urine. It also includes a box that controls external light to ensure better quality of the results. From a "fan" standpoint, it's an awesome device and technology. You can see it demo-ed during the TED talk given by the company's CEO.

Several people and organizations have opined that this particular scenario provides insight into the FDA's revised thoughts on mobile medical applications, to be released in this Fall. My thoughts? This "It has come to our attention..." letter and any subsequent action are reflective of the previously-released FDA thoughts.

The previous FDA guidance document basically said "if you're a mobile application functioning like a medical device, you're a medical device." The uChek app and accessories are functioning together as a medical device to analyze urine. That then begs the question of the particular regulatory strategy, so let's do one quickly!

Without much knowledge of the product, let's assume it is a Class I product:

  • Device: Urine Screening Kit
  • Review Panel: Microbiology
  • Product Code: JXA
  • Submission Type: 510(k) Exempt
  • Regulation Number: 866.2660
  • Device Class: 1
  • GMP Exempt? No

With that quick run-through, it seems apparent that the FDA is wrong, right? Not so fast - if you pull up the product code JXA (or most product codes for that matter) you will find yourself greeted by a few paragraphs of caveats at the end, most notably pointing you to 21 CFR 8xx.90 - limitations of exemptions clause for each sub-set of devices. In those exemptions, it calls out exemption voiding criteria:

  • a medical device that differs in its intended use than those typically understood and used in that generic device type;
  • a medical device that differs in its fundamental scientific technology than the legally marketed generic devices; or
  • a slew of in vitro device characteristics, most notably clause (c)(9) "for near patient testing (point of care)".1

There are a few issues: The app employs new technology - the phone's camera and a software algorithm to calculate the color of the test strip to analyze the test and provide results. Also, the test is intended for near patient testing. RQS has seen many companies trying to fit within a Class I, 510(k) exempt structure while utilizing a novel technology previously unused by that device type. Recently, FDA has cracked down on the orthotic industry for including electronics and assisting technology into their devices, stating that a 510(k) is required because the inclusion of this technology voids the exemption requirements.

The many-layered onion of FDA regulation continues to reveal its layers, but I don't think we need to wait until Fall to know what FDA is expecting to do in its regulation of mobile medical applications.

-RTK

Image Credit: Yutaka Tsutano at Flikr

1 CFR - Code of Federal Regulations Title 21 - Part 866 - Subpart A - Section 866.9." FDA Access Data. U.S. Food and Drug Administration, 1 Apr. 2013. Web. 17 July 2013. <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=866.9>

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