FDA Considers Regulating Wellness Technologies to Help Prevent Medical Device Defects
Advancements in technology have helped Americans live healthy lives, but developments in medical and health devices have raised several questions about the preventing defective medical products from reaching consumers.
Most of us concede the importance of regulations placed on items like insulin pumps or dialysis machines, but what about heart monitors people wear on their wrists while working out? Should over-the-counter gadgets be required to face the same regulations? Officials from the federal government say the answer to that question is yes.
According to Engadget, the U.S. Food and Drug Administration (FDA) is calling for public opinion on a set of rules to guide the design, manufacturing, and distribution of what’s being described as “general wellness devices.” These regulations will be placed on any device that claims to make improvements to a person’s health.
The problem is, the lines are very murky between claims to improving wellness and the treatment of medical conditions. That’s why the FDA is expected to make several changes to the drafted rules before a vote on the initiative is taken.
At Ferrer, Poirot & Wansbrough, we see the results of faulty products on a daily basis. Our defective medical device lawyers are anxious to see if these new regulations are put into place.