Get Priorities Right On Medical Devices
Decisions on whether to allow sale of new medical devices that could save lives ought to have priority over those on, say, improved wheelchairs, right? That probably seems obvious to most people.
It has not been as apparent to officials of the U.S. Food and Drug Administration, to judge by an Associated Press report.
On Tuesday, the AP reported the FDA is considering a new Expedited Access Program for companies that are developing new medical devices with the potential to address “critical and unmet needs.” That includes equipment to treat debilitating conditions as well as life-threatening diseases.
If the system goes through, it would accelerate the FDA approval process for such devices.
But the agency already has an accelerated approval program for “well-established” types of devices, such as wheelchairs, the AP reported.
Some people may wonder what took the FDA so long to get its priorities in order. Better late than never, we suppose.