FDA lifts CRM warning against Boston Scientific
Device Regulation Alert: Safety, Compliance and Reimbursement News, April 30, 2007
The FDA has lifted a warning against Guidant after Boston Scientific, which acquired Guidant last year, resolved quality control issues in the cardiac rhythm management (CRM) facility. In December 2005, the FDA issued a warning letter against the company after an inspection revealed the deficiencies. The warning prevented Guidant from introducing certain products, and lifting it removed all associated restrictions.
The FDA re-inspected Guidant's facilities in November and December 2006 and also assessed the new quality system improvements that Boston Scientific has implemented in response to the letter.
Boston Scientific acquired the troubled company and has put considerable resources into resolving its deficiencies, reports the Boston Globe. Although the CRM warning has been lifted, Boston Scientific is still operating under another FDA warning letter that applies to its drug-coated stents and other areas, according to the report.
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