The Food & Drug Administration is sticking to its 30-day timetable for a review of Boston Scientific Corp.’s (NYSE:BSX) implantable defibrillator manufacturing operations, which the company pulled off the market earlier this month.
The March 15 pullback was due to a pair of changes to its processes about which the Natick, Mass.-based devices giant failed to notify FDA. In a letter to physicians sent after the rollback, BSX said it expected the FDA’s review to come quicker than the 30-day deadline, according to the Wall Street Journal.
But an FDA official told the Journal that the watchdog agency won’t be speeding up its timetable for the review.
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“[The BSX submission is] in the queue, and we’re going to take it when it comes up,” Gladys Rodriguez, an enforcement director at the Center for Devices and Radiological Health, told the newspaper. “At this point, we’re not expediting.”
Boston Scientific is losing an estimated $5 million a day in sales while the devices are off the market, Sanford Bernstein analyst Derrick Sung told the Journal.
Boston Scientific announced the move March 15, saying it would hold all shipments of its implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators and pulling all inventory from the field. The company changed the cleaning process for its ICDs in March 2009, to bring it in line with an already approved process for cleaning its pacemakers. But the company did not notify the FDA of that change or of the addition of a new component supplier the following month.
Those aren’t the only BSX paperwork snafus the FDA is investigating, according to Rodriguez, who told the Journal that no injuries appear to have been caused by the manufacturing changes but wouldn’t detail the penalties Boston Scientific could face.
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The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
