Are You a Medical Device Manufacturer without Knowing It?

On November 17, 2016 in Washington, D.C., attendees of the CTeL Executive Telehealth Summit will turn their attention to the conditions under which organizational use of telemedicine technologies may trigger unwanted Food and Drug Administration (FDA) attention.

Medical devices are subject to FDA approval, and failure to have a device approved can swiftly result in sanctions and interruption of your business practice.

If your organization has a telemedicine technology that includes a peripheral device or other device that engages with the patient, and you license, provide, or sell that technology to parties outside your healthcare system, practice, or hospital, you may be at risk for FDA sanctions.

The FDA uses a unique lens to determine if an organization is operating as a medical device manufacturer. Panelists from the FDA will share what they are focusing their sights on and the metrics they use to identify organizations operating as medical device manufacturers and subject to FDA oversight.

Joining the FDA on this panel will be telehealth attorneys who will share their legal and compliance expertise around this emerging issue.

Click here to register for the Fall 2016 CTeL Executive Telehealth Summit.

Click here to view the Fall 2016 Summit agenda.

 

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