<!– –> <!– Page Last Updated: 07/22/2016 –> Page Last Updated: 07/22/2016 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Evaluation of Automatic Class III Designation (De Novo) Classification Order (DEN160003 added)
<!– –> <!– Page Last Updated: 07/22/2016 –> Page Last Updated: 07/22/2016 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Class I Medical Device Recall: Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions) Recalls Flush Angiographic Catheter Due to Tip Separation
<!– –> <!– Page Last Updated: 07/22/2016 –> Page Last Updated: 07/22/2016 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
FDA/Patient Workshop
The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) is announcing an interactive, in-person workshop entitled “Partnering with Patients on CDRH’s Research Agenda for Assistive and/or Neurostimulation Devices” The purpose of this workshop is to receive feedback on patient needs and experience regarding the usability, benefits, and desired features of medical…
Medical Device Interoperability
What is Medical Device Interoperability? Medical device interoperability is the ability to safely, securely, and effectively exchange and use information among one or more devices, products, technologies, or systems. This exchanged information can be used in a variety of ways including display, store, interpret, analyze, and automatically act on or control another product. As electronic…
WEN by Chaz Dean Cleansing Conditioners: FDA Statement
[Posted 07/19/2016] AUDIENCE: Consumer, Family Practice, Dermatology ISSUE: The FDA is investigating reports of hair loss, hair breakage, balding, itching, and rash associated with the use of WEN by Chaz Dean Cleansing Conditioner products. While the FDA continues its investigation, consumers should be aware of reactions reported in association with the use of WEN by…
Meeting materials posted for July 21-22, 2016 Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee
<!– –> <!– Page Last Updated: 07/19/2016 –> Page Last Updated: 07/19/2016 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Webinar Presentation and Transcript posted for Draft Guidance on Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions
On Monday, July 11, 2016, the FDA will host a webinar to share information and answer questions about its draft guidance entitled ‘Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.’ This draft guidance released on June 15, 2016, focuses on the factors the FDA may consider when making decisions…
Emergency Use Authorizations – Viracor-IBT Laboratories, Inc.'s Zika Virus Real-time RT
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…
Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150004 added)
<!– –> <!– Page Last Updated: 07/19/2016 –> Page Last Updated: 07/19/2016 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.