Public Workshop

The Food and Drug Administration (FDA) is announcing a public workshop entitled “The Role of Hospitals in Modernizing Evidence Generation for Device Evaluation: Harnessing the Digital Revolution for Surveillance.” Hospitals play a critical role in the development of these national capabilities, leading to more robust evidence generation. Recently, the role of hospital reporting of device-related…

Reporting Allegations of Regulatory Misconduct

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…

Class I Medical Device Recall: St. Jude Medical Recalls Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D) Due to Premature Battery Depletion

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…

Class I Medical Device Recall: HeartWare Recalls Ventricular Assist Device Pumps Due to Contamination Causing Electrical Issues

<!– –> <!– Page Last Updated: 10/21/2016 –> Page Last Updated: 10/21/2016 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français |…

EQUIP: Enhancing Quality Using the Inspection Program

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))….

Discontinue Use of Multidata Systems International Corp. Radiation Therapy Devices

October 20, 2016 Dear Radiation Oncologists, Medical Physicists, Dosimetrists, and Radiation Therapists: The FDA is concerned about the risks to patients from the use of devices manufactured and sold by Multidata Systems International Corporation (“Multidata”). The FDA knows of at least two Multidata medical devices that the company manufactured and distributed in the United States…

Class I Medical Device Recall: TeleFlex Medical Recalls Tracheostomy Tube Set Due to Possible Disconnection During Patient Use

<!– –> <!– Page Last Updated: 10/20/2016 –> Page Last Updated: 10/20/2016 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français |…