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Class I Medical Device Recall: Baxter Corporation Recalls 50 mm 0.2 Micron Filter Due to the Potential for a Missing Filter Membrane and Possible Particulate Matter Contamination
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Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting entitled “Medical Device User Fee Amendments.” The purpose of the meeting is to discuss proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA) for fiscal years (FYs) 2018 through 2022. MDUFA authorizes FDA to collect fees and use them for…
Transcript posted for September 15, 2016 National Mammography Quality Assurance Advisory Committee Meeting
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September 2016 PMA Approvals
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Meeting Notice: November 9-10, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-2880] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; establishment of a public docket; request for comments. SUMMARY: The Food and Drug Administration…
Public Workshop
The Food and Drug Administration (FDA) is announcing the following “CDRH Veteran Amputee Device Workshop.” The purpose of this workshop is to engage all stakeholders involved in the research, development, and marketing of prosthetic limb medical devices used by veteran amputees. A specific goal is to engage veteran amputees who use prosthetic limb medical devices…
Public Workshop
The Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the National Library of Medicine (NLM) of the National Institutes of Health (NIH), the Office of the National Coordinator for Health Information Technology (ONC), and the Centers for Medicare and Medicaid Services (CMS) are announcing the following public workshop entitled “CDC/FDA/NLM/ONC/CMS…
Presentation and Transcript added to Webinar – Final Guidance on Patient Preference Information
On August 23, 2016, the FDA published the final guidance on Patient Preference Information – Voluntary Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling. It outlines recommendations on patient preference studies that may result in valid scientific evidence and how stakeholders, including industry and…
Updated Information on Reducing Risks Associated with Medical Device Misconnections
Background Medical Device Misconnections Reducing Risks The FDA’s Role home setting, and other environments beyond professional health care facilities. Patients may have to use these devices for the duration of an illness, recuperation, long-term care, or throughout their lives. Examples of Medical Device Misconnections page, which includes case studies of errors and how to correct…