InTouch Health out of Santa Barbara, CA received expanded FDA clearance for its line of clinical telepresence devices now to be used to monitor high-risk patients. The indication, according to the announcement, is specifically for “pre-, peri-operative and post-surgical, cardiovascular, neurological, pre-natal, psychological and critical care assessments and examinations.”
It seems, though, that this clearance is simply an attempt by the company to catch up to new FDA regulations that appeared since these devices came to market.
Explanation from the announcement:
This clearance is part of InTouch Health’s regulatory commitment to increase its level of compliance with the FDA February 14, 2011 announcement regarding Medical Device Data Systems (MDDS). 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 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 solutions, such as InTouch Health’s telemedicine 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.
The MDDS final rule also states if a third-party company or hospital (i) develops its own software protocols or interfaces that have an intended use consistent with an MDDS, or (ii) 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 regulations.