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FDA Regulation of
Epstein Becker Green Provides Summary of FDA's Emerging Regulatory Framework
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In October 2011, Epstein Becker Green (EBG), one of the premier healthcare law firms in the United States with over 35 years of experience with federal regulations, drafted a legal opinion on behalf of InTouch Health®. In the opinion, EBG summarizes the current FDA regulations for telemedicine and mobile health products, and how they apply specifically to InTouch Health's suite of Telemedicine Solutions. In February 2011, the FDA announced the Medical Device Data Systems (MDDS) Final Rule, which defines an MDDS as a device through which medical data is passively communicated. As an FDA Class I device, an MDDS is not intended to be used for Active Patient Monitoring (e.g. stroke assessment, ICU rounding). Any device that transmits medical data that is used in decisions to take immediate clinical action by a health care professional is regulated at a higher level (Class II or Class III). The MDDS Final Rule is published in the Code of Federal Regulations 21 Part 880, Docket No. FDA-2008-N-0106. "From its inception, InTouch Health recognized its responsibility as a medical device manufacturer and thus sought and received FDA class II 510(k) clearance in 2008," commented InTouch Health CEO, Dr. Yulun Wang. EBG clearly states that InTouch Health's Telemedicine Solutions are "intended for use in active patient monitoring. Therefore, InTouch Health's products fall outside of the MDDS Class I designation and are regulated as Class II medical devices." For a complete view of the Epstein Becker Green opinion, please click here. |
