The Empire Strikes Back: FDA Blasts New 510(k) Study

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Michael Causey, Editor & Publisher,

It may not be quite as epic as the intergalactic battles in the Star Wars saga, but it’s still heating up to be a pretty juicy fight.

This week, the FDA took the relatively unusual step of publicly and directly challenging an interesting and controversial study conducted by Stanford University but funded by The Advanced Medical Technology Association (AdvaMed) that says FDA regulatory policies are stifling medical device innovation and costing those companies much more than counterparts in Europe.

Pointing to what he called “several significant flaws,” FDA spokesman Dick Thompson said the study “compared apples to oranges because companies come to the FDA earlier in the device development cycle than they do in the EU,” as reported by Devices & Diagnostics Letter.

FDA also criticized what it characterized as a low response rate for the study. Some 20 percent of the more than 1,000 companies contacted actually responded. Thompson suggested the relatively low response rate could have produced biased results.

Not surprisingly, medical device folks we’ve spoken with by and large heartily endorse the AdvaMed/Stanford report’s findings. Consultants and former FDA inspectors also tell us it’s generally on target, though they are less vehement than medical device personnel.

The study was released Nov. 18. AdvaMed President Stephen Ubl that day commented, “this report is a wake up call for those who want to promote medical innovation and preserve American jobs.” He also said the study “shows that timely patient access to new technologies and industry competitiveness are being held back because of inefficiencies that must be addressed. We urge FDA to review the findings of this study and we are committed to working with them to address these issues.”

Well apparently FDA did review them, and came to quite a different conclusion.


In September, AdvaMed released a study it said demonstrated the “ strong safety record of FDA’s premarket review process for low- and moderate-risk devices. That study, conducted by the research firm Battelle Memorial Institute, found that of the nearly 47,000 medical devices cleared by FDA through the 510(k) process since 1998, only 0.16 percent were involved in a serious recall event.

“This study highlights the remarkable safety record of FDA’s 510(k) process,” said AdvaMed Chairman James V. Mazzo, president of Abbott Medical Optics.

AdvaMed is on record saying it backs recommendations regarding increased reviewer training, development of additional guidance, and greater communication of reviewer decision rationale could address these deficiencies that result in delays and inconsistencies in the program.

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