Janosky appointed to FDA Medical Device Resolution Panel

Janine Janosky, dean, College of Education, Health, and Human Services

Enter Janine Janosky. The dean of University of Michigan-Dearborn’s College of Education, Health, and Human Services has been appointed to the five-member FDA Medical Device Resolution Panel.

Panel members provide advice and recommendations to the FDA center director on scientific disputes between the FDA and device applicants or manufacturers. The federal government established the independent panel of experts in 1997 in an effort to ensure objectivity and fairness.

“Issues considered by the Medical Device Dispute Resolution Panel are only issues that lack a resolution, that are highly complex in nature or are presented to the panel for resolution since they involve challenges to an FDA decision or action,” Janosky said.

“Through service on this panel, we are in the position to consider the safety and effectiveness, by weighing any probable benefit to health from the use of the device against any probable risk of injury or illness from such use, among other relevant factors is first and foremost. First and foremost, we are considering the safety of health of individuals and of the health of the public.”

Since 1995, Janosky has served as an FDA advisory committee member and consultant, working primarily with the Center for Devices and Radiological Health. Her current panel appointment runs through September 30, 2017.