By Jeffrey N. Gibbs & Allyson B. Mullen
Imagine that you were working at a device company and you received a letter today from FDA saying that FDA was “correcting” the FDA clearance you received nineteen (19 – that is not a typo) years ago. You would probably think about all the things that have changed in 19 years, your original 510(k) submission not being among them: a second gulf war, 9/11, the Great Recession, our first African-American president, the Red Sox finally winning a world series (and then two more), the Yankees winning five world series, and the Cubs – well not everything changes. Then you might suspect that this was just an April Fool’s prank. It probably isn’t.
Recently, we found a letter from FDA that did precisely that. According to FDA’s 510(k) database, the Whatman Body Fluid Collection Paper was originally cleared via K932661, on April 17, 1996. On February 6, 2015, FDA sent the company a letter stating “this letter corrects our substantially equivalent letter of April 17, 1996” (a copy of the letter can be found here). The letter offered no explanation for why the correction was issued, let alone why FDA felt it needed to correct a clearance letter issued during the first term of the Clinton Administration. It is possible, however, that the nature of the correction may simply not be clear to us because of the limited information available regarding this 510(k) due to its age.
