“The FDA is falling short in how it handles recalls of risky medical devices, a new report from the Government Accountability Office concluded, adding to the ever-mounting criticisms of the agency’s fast-track, 510(k) approval process.”
The Government Accountability Office (GAO) is known as “the investigative arm of Congress” and “the congressional watchdog.” GAO supports the Congress in meeting its constitutional responsibilities and helps improve the performance and accountability of the federal government for the benefit of the American people.
In a recent article, the GAO complained that the FDA failed to keep track of the reasons devices such as hip implants are recalled, and it doesn’t always follow up to make sure the recall was complete.
Click here to read the article: GOA Still Leary of Fast-Track Device Approvals
The GAO is only the most recent group to criticize the FDA for the 510(k) fast-track approval process for medical devices.
Click here to read a previous post about the high recall rate for fast-tracked medical devices.