When it comes to the newest and most-advanced medical devices, Europe is getting them first, according to a study released Tuesday morning by a group of researchers at Northwestern University in Chicago.
Researchers queried more than 350 professionals in the medical device industry to determine how a popular way of gaining Food and Drug Administration (FDA) clearance for new products, called the 501k process, was working. The conclusion: It's not. And as a result, the U.S. is falling behind other countries in medical technology advances, the study alleges.
Two-thirds of those surveyed in the query felt Europe's regulatory system was more predictable than the FDA in the United States. Specifically, only 8 percent of those surveyed felt the FDA's 510k process, which generally does not require clinical studies on humans, was the most-predictable in the world.
Other complaints about the FDA centered around unclear regulatory guidelines, inconsistent implementation and the rapid turnover of reviewers assessing a new medical device. About 98 percent of those surveyed said the predictability of FDA requirements was a major determinant in whether to invest in a new product.
The study was funded by the Institute for Health Technology Studies, or InHealth, a nonprofit foundation that "supports research and analysis into the role of medical technology in advancing health care and patient quality of life."
John Linehan, a biomedical engineering professor at Northwestern, noted that the U.S. regulatory system has been known for high quality standards and innovation in new medical devices. But uncertainty surrounding the 510k process is posing challenges for the FDA and the industry that could lead to a "brain drain" in medical technology, he said.
The agency is currently mulling changes to the 510k process, and the Institute of Medicine is expected to release a report this summer, as well.