Wearable Sensors and Electronics 2014

Jitty Malik presented "Government regulations: the impact on wearable device manufacturers" at this conference hosted by MEMS Journal, Inc.  Wearable sensors are becoming increasingly prevalent in our society to monitor various aspects of human activity, including human physiology. Accordingly, the U.S. Food and Drug Administration ("FDA") is becoming increasingly vigilant in monitoring certain wearable technologies. Congress also is signaling its intent to scrutinize the information wearable devices collect and process. Recently, the FDA issued guidance explaining which wearable devices it intends to regulate and how it intends to regulate them. Depending on the intended application, a wearable device manufacturer could subject themselves to scrutiny from the FDA. The FDA's regulations will have broad implications for developers of wearable technologies. Topics covered in the session included, FDA regulations, including which wearable devices will be regulated by the FDA, how the FDA will make a determination whether a wearable device will be subject to its regulations, and an overview of the kinds of information a manufacturer will have to provide to comply with the regulatory regime. Some device manufacturers have already approached the FDA, and their discussions with the FDA have been made public. The contents of these discussions will be presented to provide the audience with a better understanding of the FDA's thoughts as it comes to its own regulations. The program covered some of the concerns expressed by Congress, and the information Congress has requested in the wearable device space, in an effort to better understand future regulatory changes.

For more information, please click here.


November 12-13, 2014
Biltmore Hotel & Suites / Santa Clara, CA