510(k) Clearance “Corrected” 19 Years after Original Clearance

April 1, 2016

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.

A similar device, the Ahlstrom 226 specimen collection paper, was originally cleared on October 19, 2007, and received a nearly identical 510(k) “correction” letter. Both the Whatman and Ahlstrom correction letters were issued on the very same day, February 5, 2015 (a copy of the letter can be found here).  Because the Ahlstrom clearance is more recent, there is a 510(k) Summary available.  The only discernable difference between the information in the 510(k) Summary and the “corrected” clearance letter is the product code.  The Ahlstrom paper was originally cleared under product code JKA (tubes, vials, systems, serum separators, blood collection devices, 21 C.F.R. § 862.1675).  The “corrected” clearance letter cites product code PJC, which is the product code for Newborn Screening Specimen Collection Paper (21 C.F.R. § 862.1675). (The legal significance of product codes is not altogether clear; that is a different topic for a different day).

While it is not unusual for FDA to change or obsolete product codes for administrative reasons, this change appears substantive in that it could affect the products’ intended use and their suitability as predicates. The Ahlstrom paper, and presumably the Whatman paper because Ahlstrom cited it as its predicate, were cleared for use “as a medium to collect and transport blood specimen spots to be laboratory.”  There was no specific assay or analyte specified in the intended use.  However, the Ahlstrom 510(k) decision summary prepared by FDA (available here) indicates that the device was tested to Clinical Laboratory Standards Institute (CLSI) standard NCCLS/CLSI LA4-A3: Blood Collection on Filter Paper for Newborn Screening Programs; Approved Standard—Third Edition.  The “corrected” product code is specific to newborn screening.  The definition of product code PJC (the “corrected” code), in FDA’s product classification database, states “newborn screening specimen collection paper is a blood collection device intended to be used as medium to collect and transport whole blood specimens from newborns to the laboratory for in vitro diagnostic analysis.”  This definition uses the nearly identical language as the Ahlstrom clearance, but is limited to newborn screening only. 

Was FDA attempting to limit the scope of the Ahlstrom clearance ex post facto? Possibly.  The public record does not say.  Anyone trying to obtain clearance for an IVD collection device (e.g., blood, saliva) today certainly knows that FDA will no longer allow a broad indication for use like the original Ahlstrom use without very extensive clinical testing. 

Seeing these letters made us wonder if this was a unique event.  It turned out that post-clearance corrections of 510(k)s are not all that unusual.  We found nearly 400 letters doing just that. (While a low frequency event, it can still be a disconcerting one for those receiving such a letter).  Based on a sampling of these letters, none of the letters appear to give an explanation for the “correction.”  Many of the letters appear to “correct” the product code originally assigned to the device.

Although this issue of changing a product code years after the 510(k) clearance may seem relatively minor, it does raise more profound questions.  What do belated "corrections" mean for the stability and predictability of the regulatory process?  Do the letters truly represent corrections, or changes in policy?  Assuming that the letters are due to changed policy, does FDA have the statutory authority to alter the scope of the clearance?  Can these changes in product code restrict the ability of other companies — and the 510(k) holder — to use the cleared device as a predicate for the indications for use for which it was cleared?  

We do not know. But, in light of the amount of effort that goes into the FDA review process for 510(k)s, it is remarkable how many post-clearance corrections there have been.  Given how long it can take to obtain a 510(k) clearance, many applicants are relieved when the process is over.  The Whatman “correction” letter shows that sometimes it ain’t actually over even when it is over. 

Reminder: Register now for the May 3, 2016 Virginia Tech and HP&M Conference on Effective Documentation.  Information on the conference is available here.

Categories: Medical Devices