William Hyman: Updated, but Not Up To Date at the FDA

November 7, 2014

Regulations

A challenge in the fast-moving medical device industry is the maintenance of up-to-date information. The U.S. Food and Drug Administration (FDA) faces this challenge in keeping its various online resources current and consistent. While FDA web pages have a “last updated” date, it is generally not possible to ascertain what exactly was updated on the date given or whether more recent data also might exist.

I recently discovered one measure of this up-to-date challenge while looking for FDA data on inferior vena cava filters, which share the product code DTK. Searching the 510(k) database using DTK yielded 63 such submissions from 14 different manufacturers. When I last looked, the 510(k) search page had a “page last updated” date of 11/3/2014. The Total Product Life Cycle page for DTK, shown as updated on 11/3/2014, had 46 submissions from nine manufacturers. The TPLC page also had two seemingly inconsistent tables of recalls. One showed no recalls of any products between 2007 and 2014. The second table showed one recall in 2007.

Searching DTK on the Medical Device Recalls database—page updated on 11/1/2014—yielded six recalls. The one recall from the TPLC page was among these six, but the five others were absent from the TPLC page. When I searched for “filters, intravascular, cardiovascular”—the official name of these products—I saw the same six, but using this full name in the advanced search “product name” box resulted in an error message, possibly because of the length of the name or the commas. The advanced search entry form does not offer product code entry, which would be useful.

Besides the vagaries of the FDA search functions, this exercise demonstrates that various portions of the agency’s web pages may not actually be up to date, regardless of the last updated date.

This reminded me of an exchange I had with my city’s zoning enforcement people when I lived in Texas. I received a harsh letter from the city that a property I no longer owned was in violation of a restriction (you couldn’t have a sofa in your front yard as college students are wont to do). I informed the city that I no longer owned this house. City officials said they based their actions on the county property owners list, which had a recent updated date. I then called the county and was informed that, yes, its database had been updated on that date, but that did not necessarily mean that it was up to date, i.e., it had been updated using data that did not include all recent transactions.

So the next time you look for current data, keep in mind that the source may not be current—regardless of the updated date.

William Hyman, ScD, is professor emeritus of biomedical engineering at Texas A&M University. He now lives in New York where he is adjunct professor of biomedical engineering at The Cooper Union.

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