Compliance In Focus

The final FDA guidance on design consideration and pre-market submission for interoperable medical devices was released on 06 September 2017. The demand for these devices is increasing in the healthcare system as our dependence on more rapid and protected interactions between devices grows. This increase presents a need for a parallel increase in adequate FDA regulations for this elaborate device field. An interoperable medical device is one with the ability to exchange and use information with another medical or non-medical product, system, or device. An electronic interface is a medium by which these systems can communicate. This type of communication or exchange between systems and devices may include transmission and/or reception, storing, analyzing, or interpreting data. Medical device manufacturers are also designing interoperable devices to perform more advanced types of data exchange such as one device issuing commands or having control over another device(s).

In 1996 The University of Rochester was offering $150 to volunteers for what was designed to be a minimal-risk research study. To 19-year-old Nicole ( Hoiyan ) Wan, a hundred and fifty dollars meant being able to afford a trip home to see her parents in Queens, New York. Nicole, like many college students, found the money offered on a campus flier for participation in the clinical research study to be extremely enticing. Back in Queens, New York, Mr. and Mrs. Wan were unaware of their daughter’s intention to enroll in any study.