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Regulatory Roundup: St. Jude Resolves Warning Letter; Classifications; IMDRF

FDA formally closed out St. Jude Medical’s warning letter that had cited deficiencies at the firm’s California defibrillator lead facility. The agency finalizes two de novo classifications. The International Medical Device Regulators Forum is set to meet in Washington, D.C., in September.

FDA has formally closed the January 2013 warning letter for St. Jude Medical Inc.’s Sylmar, Calif., cardiac rhythm management device manufacturing facility. The agency sent the “close-out” letter

to St. Jude group president Eric Fain on June 30.

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