In a press release released by the FDA today, the agency announced that an orthopedic device used in the knee should not have been cleared for marketing in the United States.
According to the FDA, a scientific re-evaluation of the device was conducted because records from the original review was not adequate to "dispel questions about the role of outside pressures on the review process."
The timing of this press release is interesting because the FDA is currently re-evaluating its medical device clearance process to see if it needs to be improved to ensure the safety and effectiveness of medical devices marketed in the U.S. Proponents of the change have argued that the current review process is not transparent enough and is susceptible to outside influences. The finding by the FDA about the orthopedic device appears to support that assertion.
