The FDA’s device arm continued it’s light-touch approach to regulating medical software and other modern health information technologies that are either relatively simple or don’t pose a clinical risk to patients. In technical terms, the FDA employed its “enforcement discretion,” meaning the agency believes it has the authority to regulate the devices but opts not to.
There were 426 medical device recalls in the first quarter of this year (2015), according to the FDA’s recall database, down from a record high of 968 in Q4 2014.
University of Pennsylvania researchers are in the early stage of developing a neural implant to help the 10 million people across the globe with traumatic brain injury improve their memory.
A national survey and study by doctors from the University of California, Los Angeles, found that defensive medicine is leading to unnecessary imaging. In the survey, 97% of emergency physicians (EPs) acknowledged ordering some scans that were not strictly necessary.
As med tech companies zero in on digital technology for healthcare monitoring, the FDA said it is allowing more room for innovation before taking a heavy hand in regulation.
Although the United States Food and Drug Administration (FDA) is taking a hands-off attitude toward regulating new forms of health information technology, the Federal Trade Commission (FTC) has stepped up enforcement of those app makers that make false or misleading claims. The development highlights Apps that have positioned themselves too far down the spectrum toward providing healthcare versus improving general wellness or fitness, as well as the FDA’s reliance on its federal cousins.
Opinions are all over the map when it comes to whether the FDA regulates medical devices too strictly or too loosely. Those favoring more regulation point to infamous examples like metal on metal hips and faulty defibrillator leads. Power morcellators and duodenoscopes are the latest additions to that list. Industry and others who favor faster access note that in Europe, many advanced devices are made available years before they are commercialized in the U.S.
The American Diabetes Association and the European Association for the Study of Diabetes have published a statement calling for the adoption of improved and harmonized safety standards for insulin pumps. The joint statement appears in the April 2015 issue of the journal Diabetes Care.