Under the program, companies could choose to submit their 510(k) information, which establishes a device is “substantially equivalent” to a prior device, to one of these third parties, referred to as “Accredited Persons,” who would review the company's 510(k) information, then recommend clearance or rejection to the FDA. The agency then has 30 days to reach a final decision on the device. A company could also choose to submit the information directly to the FDA.
But the thinking was, let specially approved third parties do the initial review, and they could do it faster.
According to the FDA, it appeared to be working—during fiscal 2002, says FDA, these outsiders' reviews resulted in “marketing clearance in an average of 77 days,” which was “20 percent faster than comparable 510(k) reviewed entirely by FDA.”
But the Wall Street Journal reported in mid-March that some FDA-ers are wondering if the third-party reviewers' reviews are of sufficient quality and whether money is really being saved.
There's some suggestion that the third-party reviewers are being more lenient than FDA in judging data. So we'll have to watch to see if the Journal's report emerges into some formal agency action about device review.
Meanwhile, the other shoe still hasn't dropped regarding serious criticisms of FDA's own internal device reviews. A little over a year ago, FDA scientists in the devices center complained to the incoming Obama administration about corruption of the scientific process. They said FDA had been “corrupted and distorted by current FDA managers, thereby placing the American people at risk.” Since then, there hasn't been any obvious result, though the new administration has repeatedly said it intends to work harder to protect the public from dangerous products.
-By Eric Greenberg, Attorney-at-Law
But the thinking was, let specially approved third parties do the initial review, and they could do it faster.
According to the FDA, it appeared to be working—during fiscal 2002, says FDA, these outsiders' reviews resulted in “marketing clearance in an average of 77 days,” which was “20 percent faster than comparable 510(k) reviewed entirely by FDA.”
But the Wall Street Journal reported in mid-March that some FDA-ers are wondering if the third-party reviewers' reviews are of sufficient quality and whether money is really being saved.
There's some suggestion that the third-party reviewers are being more lenient than FDA in judging data. So we'll have to watch to see if the Journal's report emerges into some formal agency action about device review.
Meanwhile, the other shoe still hasn't dropped regarding serious criticisms of FDA's own internal device reviews. A little over a year ago, FDA scientists in the devices center complained to the incoming Obama administration about corruption of the scientific process. They said FDA had been “corrupted and distorted by current FDA managers, thereby placing the American people at risk.” Since then, there hasn't been any obvious result, though the new administration has repeatedly said it intends to work harder to protect the public from dangerous products.
-By Eric Greenberg, Attorney-at-Law
