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Medical Devices / Regulatory Affairs

FDA Advances Plans for a Digital Health Unit

May 12, 2017

The FDA is moving ahead with the creation of a Digital Health Unit to address software validation for devices and other issues relating to health information technology.

The unit is first tasked with establishing clinical validation procedures that can be applied to software, since software is increasingly functioning as a medical device, said Bakul Patel, CDRH’s associate center director for digital health, at an Ohio medical conference last week.

Wearable technology is growing in popularity and devices are increasingly digitized and connected, so regulations and consumer protections have to keep pace, taking into consideration all the advantages and disadvantages of digital devices, he said.

CDRH is seeking to enable patient-centered public health as digitization moves into every aspect of health care, foster trust in innovative technologies as an enabler of a new health care paradigm and partner with stakeholders to be “digital-future ready,” said Patel.

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