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Boston Scientific CRM update

This article was originally published in The Gray Sheet

Executive Summary

FDA is reviewing Boston Scientific's catch-up submissions covering manufacturing process modifications to its implantable defibrillators and cardiac resynchronization therapy defibrillators under the 30-day notice process, an FDA spokeswoman confirmed last week. The company pulled all of its ICD and CRT-D products off the market March 15 after it identified two manufacturing changes that were never submitted to the agency for pre-review, at the cost of about $5 million per day in lost sales, analysts estimate (1"The Gray Sheet" March 22, 2010). Boston Scientific sales reps have told electrophysiology practices to expect resolution within 30 days, with potential for approval for the changes in as little as eight business days. But FDA's Peper Long also confirmed a statement by a CDRH staffer in the March 26 Wall Street Journal that the agency is "not expediting" the firm's submissions at this point
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