Apple Inc. and FDA Discusses New Product w/ Sensors and Glucometer
By Athena Yenko | June 11, 2014 11:33 AM EST
On Dec 2013, senior executives of Apple Inc. met with the United States Food and Drug Administration. What transpired during the meeting was kept confidential at that time.
On Monday, it was made public that the meeting was a discussion on a new product with sensors and glucometer and how the committee plans to regulate these new Apple features. This information was revealed by the Memorandum of Meeting obtained through Freedom of Information Act sought by Apple Toolbox.
The meeting was attended by Apple's executive - Jeff Williams, Senior Vice President of Operations Bud Tribble, MD-PhD, Vice President of Software Technology Cathy Novelli, Vice President of Worldwide Government Affairs Michael O'Reilly, MD MS, Vice President of Medical Technologies Tim Powderly, Director of Federal Government Affairs - and FDA officers - FDA: Margaret Hamburg, Sally Howard, Jeff Shuren, Bakul Patel, Jeff Shiffman.
The document revealed that Apple particularly sought information on how FDA will regulate a device with sensors and a glucometer. As suggested and reflected by various reports, the device in question could be the iWatch.
As per FDA regulation, the sensor per se will not undergo regulation but the software powering the sensor will be regulated. The software shall not render the device to function as a medical device.
"For instance, a glucometer would be considered diagnostic because it measures blood sugar; it would not be considered merely information although it "informs" the user of the blood sugar level. The display screen of the glucometer would not be regulated, as it only receives the data and shows it. The software that does the measuring is the part that is regulated," FDA upheld.
"... the glucometer may be unregulated if the intent is for a user to follow their blood sugar for the purposes of better nutrition. If the glucometer is marketed for diabetics, however, it would more likely be regulated as a medical device," FDA emphasised.
Incidentally, Apple was granted a patent for a weightlifting tracking system on Tuesday. The US Patent and Trademark Office gave Apple US Patent No. 8,749,380 which declares a that "Shoe wear-out sensor, body-bar sensing system, unitless activity assessment and associated methods," AppleInsider reports.
The tracking system was designed with a separate sensor to reflect data to a remote display. The remote display could possibly be the iWatch.
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