Sonali P. Gunawardhana

Transcription

1 BLOOD, SWEAT & TEARS III Diverse Applications and Common Manufacturing Technologies for Wearable Human-Monitoring Devices November 2-3, 2016 Sonali P. Gunawardhana Counsel 1776 K Street, NW Washington, DC (202) sgunawardhana@wileyrein.com

2 FDA Oversight of Digital Health Including Wearables In 2012, FDA identified the challenges to device interoperability at a Summit on Medical Device Interoperability with the Association for the Advancement of Medical Instrumentation. In 2013, FDA officially recognized a set of standards manufacturers could use to improve patient care by making sure devices work well together. (Guidance for Industry and Food and Drug Administration Staff; Radio Frequency Wireless Technology in Medical Devices) In 2015, FDA encouraged the development of devices that can openly transfer, store, display, or convert data by finalizing our policy in guidance on medical device data systems (MDDS).

3 Final Guidance Documents/ Federal Register Notices General Wellness: Policy for Low Risk Devices Guidance for Industry and Food and Drug Administration Staff (July 2016) FDA Solicits mhealth, Wearable Tech Info For Clinical Trials (October 2015) The movement towards decentralized monitoring and care is creating incentives to develop new remote patient monitoring systems, homeand self-care products, wearable diagnostic devices using new types of biosensors, and mobile lab-on-a-chip systems for clinical laboratory tests. FDA recognizes this and has cleared and approved a variety of different innovative medical devices.

4 Examples of Recent FDA Cleared Wearables

5 Future FDA Oversight of Wearables Meet the definition of general wellness product: (1) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions an where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.

6 Falling Outside of the Low Risk Parameters The product is invasive (penetrates or pierces the skin or mucous membranes of the body) The product is implanted If the product involves an intervention or technology that may pose a risk to the safety of users and other persons if specific regulatory controls are not applied (risks for radiation or laser exposure)

7 Take Away Message Currently due to the ever changing landscape of digital health, FDA plans to continue to use guidance documents to clarify its position regarding oversight. If you do not meet the general wellness definition and you meet the legal definition of a medical device then you will need to obtain FDA clearance or approval for your product. FDA oversight all revolves around the intended use and the safety profile of the product.

8 Vital Connect HealthPatch MD Biosensor The VitalConnect Platform wireless physiological monitoring system received FDA clearance effective April 3, 2014, July 29, 2014, and December 6, The HealthPatch MD detects the following vital signs and biometric measurements: Single-Lead ECG Heart Rate RR Interval Heart Rate Variability Respiratory Rate Skin Temperature Body Posture Fall Detection Activity including Steps

9 Coordination with Federal Communications Commission (FCC) The Federal Communications Commission (FCC) oversees the use of the public radio (RF) spectrum within which RF wireless technologies operate. The FDA coordinates its policies on wireless medical device with the FCC to improve government efficiency in the oversight of broadband and wireless enabled medical devices. FDA recognizes that the incorporation of wireless technology in medical devices can have many benefits including increasing patient mobility by eliminating wires that tether a patient to a medical bed, providing health care professionals the ability to remotely program devices, and providing the ability of physicians to remotely access and monitor patient data regardless of the location of the patient or physician. These benefits can greatly impact patient outcomes by allowing physicians access to real-time data on patients without the physician physically being in the hospital and allowing real-time adjustment of patient treatment.

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