Reusable medical devices are devices that health care providers can reuse to diagnose and treat multiple patients. Examples of reusable medical devices include surgical forceps, endoscopes and stethoscopes. When used on patients, reusable devices become soiled and contaminated with microorganisms. To avoid any risk of infection by a contaminated device, reusable devices undergo “reprocessing,” a…
Emergency Use Authorization: OraQuick® Ebola Rapid Antigen Test (OraSure Technologies, Inc.)
On November 10, 2014, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the RealStar® Ebolavirus RT-PCR Kit 1.0 for the presumptive detection of RNA from Ebolaviruses [such as Zaire ebolavirus (including the Zaire ebolavirus strain detected in the West Africa outbreak 2014), Sudan ebolavirus, Tai Forest ebolavirus, Bundibugyo ebolavirus,…
Cybersecurity Vulnerabilities of Hospira Symbiq Infusion System: FDA Safety Communication
Date Issued: July 31, 2015 Audience: Health care facilities using the Hospira Symbiq Infusion System Device: Symbiq Infusion System, Version 3.13 and prior versions The Hospira Symbiq Infusion System is a computerized pump designed for the continuous delivery of general infusion therapy for a broad patient population. It is primarily used in hospitals, or other…
FY 2016 Medical Device User Fee Small Business Qualification and Certification
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Posted the July 30, 2015 MDUFA III Quarterly Performance Report
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Public Workshop FDA/CDC/NLM Workshop on Promoting Semantic Interoperability of Laboratory Data, September 28, 2015
The Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the National Library of Medicine (NLM) of the National Institutes of Health are announcing the following public workshop entitled “FDA/CDC/NLM Workshop on Promoting Semantic Interoperability of Laboratory Data.” The purpose of the workshop is to receive and discuss input from…
Correction: Letter to 510(k) Holders of Endoscope Devices classified with product code KOG
Date: July 30, 2015 Dear Endoscope Device Sponsor: This letter is to advise you of a correction to the July 27, 2015 letter you received regarding CDRH’s decision to retire product code KOG. Under the section “What You Should Do – Update Listing Information” we instructed you to update your listing in FURLS to reflect the…
Updated the Topics within CDRH Innovation
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Summary Information for: ReShape Integrated Dual Balloon System
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Presentations and Webcast added to Public Workshop – Robotically-Assisted Surgical Devices: Challenges and Opportunities, July 27
The Food and Drug Administration (FDA) is announcing a public Workshop entitled: “Robotically-Assisted Surgical (RAS) Devices: Challenges and Opportunities.” The purpose of this workshop is to obtain public feedback on scientific, clinical and regulatory considerations associated with RAS devices. Comments and suggestions generated through this workshop will facilitate further development of regulatory science for RAS…