DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-2147] General and Plastic Surgery 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…
Meeting materials posted for August 10, 2016 Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee meeting
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Meeting materials posted for August 10, 2016 Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee meeting
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0.25 Percent Bupivacaine Hydrochloride Injection, USP by Hospira: Recall
[Posted 08/05/2016] AUDIENCE: Pharmacy, Risk Manager, OBGYN, Dentistry ISSUE: Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of 0.25% Bupivacaine Hydrochloride Injection, USP (NDC: 0409-1159-02, Lot 59-064- DK, Expiry 1NOV2017) at the hospital/retail level due to the presence of particulate matter within a single vial. In the event that the particulate is administered…
VentStar Oxylog 3000 Pediatric Patient Breathing Circuit by Dräger: Class I Recall
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Webinar Presentation and Transcript added to Next Generation Sequencing (NGS) Draft Guidances: Technical and Regulatory Aspects
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Announcing Two Draft Guidance Documents Clarifying When to Submit a 510(k) for a Change to an Existing Device and FDA Webinar on August 25, 2016
Today the FDA released two draft guidance documents: “Deciding When to Submit a 510(k) for a Change to an Existing Device,” which applies to medical device changes broadly, and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device,” which focuses on software-specific changes. Medical device technology is constantly evolving, and…
Deciding When to Submit a 510(k) for a Change to an Existing Device
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Deciding When to Submit a 510(k) for a Software Change to an Existing Device
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Emergency Use Authorizations
On February 26, 2016, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Centers for Disease Control and Prevention’s (CDC) Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) for the presumptive detection of Zika virus-specific IgM in human sera or cerebrospinal fluid (CSF) that is submitted alongside…