Patients Will Feel the Pain of FDA Burden on Medical Device Makers: New at Reason

Getting new medical devices to market through the Food and Drug Administration’s (FDA) regulatory gauntlet isn’t getting any easier. An FDA medical labeling rule change currently in its comment period would add an additional 1.6 million hours to the workload of private sector workers and federal regulators, in an industry that is already hobbled by red tape.

Rules like that don’t just stifle innovation and hurt businesses, argues J.D. Tuccille. They harm the people who depend on the sometimes life-saving products those businesses develop and distribute.

Under the growing bureaucratic burden, writes Tuccille, the entrepreneurs whose businesses founder or just never get launched won’t suffer nearly as much as the people who would have benefited from their innovations.

View this article.