Decades after Congress broadened the agency's authority to devices, the FDA had yet to finish setting standards to categorize products by riskiness. The FDA dawdled as huge application backlogs developed. The number of approvals fell steadily from 1989 to 1992, before rebounding slightly in 1993. The average review time jumped by 60 percent, to 141 days, hitting 200 days in early 1993 and 216 in 1994, before dipping to 185 in early 1995. Approval times for more complex goods exceed two years, running at 823 days in 1994.
Some reviews take even longer, compared to an average of six to eight months in Europe.
Naturally, the FDA's response two years ago to criticism was to tighten its controls. Only after the 1994 election did the FDA make a concerted effort to reduce approval backlogs. The ultimate victims of stifling FDA bureaucracy again are patients. New and improved medical products would enhance people's lives in a number of areas, ranging from heart and coronary disease to ligament repair. Unfortunately, federal regulation stands in the way of these advances.