FDA and FCC to work Jointly on the Development of Wireless Medical Devices

Hello!

Last week the Food and Drug Administration and the Federal Communications Commission issued a joint statement regarding their intent to proactively address issues that arise when medical devices send patient information to physicians wirelessly.  Issues such as the reliability and privacy of the communication are of particular concern.  If the communication link is not reliable it could affect patient care and health outcomes if vital data is either incomplete or simply not received by the physician.  It is also vitally important to ensure that patient data cannot be obtained by eavesdropping or overt hacking.

You may read the agencies’ statement at: http://www.fda.gov/MedicalDevices/NewsEvents/ucm220277.htm

Bioscience Translation & Application has expert associates ready to serve you in the area of medical device regulation and we welcome your questions regarding these products.Visit us at www.BioTransApp.com.