An allegation of regulatory misconduct is a claim that a medical device manufacturer or individuals marketing medical devices may be doing so in a manner that violates the law. Reporting these allegations can help make the FDA aware of regulatory concerns it may not learn of otherwise. This information can help the FDA identify the…

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The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product(s): Fortify, Unify, and Assura Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D) Model/Item Numbers: See “Full List of Affected Devices” Manufacturing Dates: January 2010 to…

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The promotion of clinical image quality is a primary goal of the Mammography Quality Standards Act (MQSA). In fact, there is a requirement in the MQSA regulations that “[c]linical images produced by any certified facility must continue to comply with the standards for clinical image quality established by that facility’s accreditation body” (21 CFR 900.12(i))….