The Food and Drug Administration announced the following public workshop entitled: “Adapting Regulatory Oversight of Next Generation Sequencing-Based Tests”. The purpose of this workshop was to obtain feedback on two FDA draft guidances, “Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases” and…
Emergency Use Authorizations: Zika Virus Detection by RT-PCR Test (ARUP Laboratories)
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…
FDA Voice blog: Using Symbols to Convey Information in Medical Device Labeling
By: Antoinette (Tosia) Hazlett, MSN, RN, and Scott Colburn CAPT, USPHS Symbols convey important messages for navigating everyday life; whether it’s a traffic sign or a graphic image indicating that no smoking is allowed in a building. Symbols in medical device labeling can also convey important information. However, to be an effective means of communicating…
Information on the Artificial Pancreas Device System
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Presentation and Transcript added to Webinar – Final Guidance on Adaptive Designs for Medical Device Clinical Studies
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Presentations posted for September 20-21, 2016 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting
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Consumer Information on: The 670G System
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for the FDA’s approval. Product Name: The 670G SystemPMA Applicant:…
Updated the Expedited Access Pathway Program website with two Data Development Plan Examples
The Expedited Access Pathway (EAP) program is a voluntary program for certain medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions that are subject to premarket approval applications (PMA) or are eligible for de novo requests. The program is detailed in the FDA’s guidance…
24 Hour Summary posted for September 20-21, 2016 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting
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Class I Medical Device Recall: DePuy Synthes Recalls Power Tool System Battery Adaptors Due to Possible Explosion Risk
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