Regulatory Roundup: St. Jude Resolves Warning Letter; Classifications; IMDRF
This article was originally published in The Gray Sheet
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.
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