InTouch Health applauds FDA for recent announcement on Medical Device Data Systems

In response to the recent announcement issued by the Food and Drug Administration (FDA) regarding Medical Device Data Systems (MDDS), InTouch Health® affirms its position of compliance, and applauds the agency for issuing regulations governing the use of hardware and software in the healthcare information technology space. The MDDS Final Rule provides clarification on the critical difference between the handling of medical device data intended simply for documentation versus that of active patient monitoring. The FDA indicated in its February 14, 2011 press release that MDDS classified devices are intended only to transfer, store, convert from one format to another according to preset specifications, or to display medical device data. The Final Rule further stipulates that as an FDA class I device, an MDDS is not intended to be used in connection with active patient monitoring (i.e. real time, active or online patient monitoring). Any device that transmits, stores, converts, or displays medical device data that is intended to be relied upon in deciding to take immediate clinical action by a health care professional is not an MDDS. Active patient monitoring devices are primarily FDA class II medical devices requiring more stringent manufacturer controls. The MDDS Final Rule is published in the Code of Federal Regulations 21 Part 880, Docket No. FDA-2008-N-0106.

"We have seen firsthand the evolution of two-way audio and video communications systems used by health care professionals, which have transitioned from distance learning and hospital administrative applications to more comprehensive patient diagnosis. As health care providers now adapt these systems for real time physician consults in acute telemedicine applications such as stroke, ICU, cardiology, trauma, and pediatric patient care, the industry must accept higher levels of responsibility to insure the safety and effectiveness of these devices," said Dr. Yulun Wang, Chairman and CEO for InTouch Health. "From the time of the FDA's Proposed Rule, InTouch Health recognized its responsibility as a medical device manufacturer and thus sought and received FDA class II 510(k) clearance in 2008."

"The Final Rule is a signal to industry that the FDA is transitioning from 'regulatory discretion' where the FDA takes a wait-and-see approach to nascent markets, to pursuing 'enforcement discretion' to actively regulate new market segments," said Stephen R. Sidwell, Director of Regulatory Affairs and Quality Assurance for InTouch Health. "We have already committed the significant time and energy to design, validate and test all of our products to the highest standards using a total quality system of procedures and processes in strict adherence to those guidelines provided by the FDA."

The Final Rule also states if a third-party company or hospital develops its own software protocols or interfaces that have an intended use consistent with an MDDS, or develops, modifies, or creates a system from multiple components of devices and uses it clinically for functions covered by the MDDS classification, then that entity would also be considered a device manufacturer and be subject to FDA regulatory law.