<!– –> <!– Page Last Updated: 09/18/2015 –> Page Last Updated: 09/18/2015 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Patient Engagement Advisory Committee
Purpose The Committee will provide advice to the Commissioner or designee, on complex issues relating to medical devices, the regulation of devices, and their use by patients. The Committee may consider topics such as: Agency guidance and policies, clinical trial or registry design, patient preference study design, benefit-risk determinations, device labeling, unmet clinical needs, available…
Class I Medical Device Recall: SynCardia Systems, Freedom Driver System
Recall Class: Class I Date Recall Initiated: August 7, 2015 Device: Freedom Driver Systems used with the SynCardia temporary Total Artificial Heart (TAH-t) Lot numbers: 85978 (Serial Numbers 85978-001 through 85978-040) 85979 (Serial Numbers 85979-001 through 85979-040) Manufactured from: November 3, 2014 to July 29, 2015 Distributed from: November 10, 2014 to July 29, 2015…
Infections Associated with Reprocessed Flexible Bronchoscopes: FDA Safety Communication
Date Issued: September 17, 2015 Audiences: Health care providers who use bronchoscopes Staff working in reprocessing units in health care facilities Infection Control Practitioners Patients considering bronchoscopy procedures Medical Specialties: Pulmonology, Otolaryngology, Cardiothoracic Surgery, Infection Control Device: All flexible bronchoscopes Purpose:The purpose of this communication is to share preliminary information regarding infections associated with the…
Agenda and Discussion Paper Posted for 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 titled “FDA/CDC/NLM Workshop on Promoting Semantic Interoperability of Laboratory Data.” The purpose of the workshop is to receive and discuss input from…
Digital Health
<!– –> <!– Page Last Updated: 09/16/2015 –> Page Last Updated: 09/16/2015 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
CDRHLearn (New Modules Added)
Premarket Notification (510k) The 510(k) ProgramPresentation Printable Slides Transcript Premarket Notification 510(k) OverviewPresentation Printable Slides 510(k) Format Guidance, Including Standards Form, and Extensions/Clinical Trial Form and 510(k)Presentation Printable Slides 510(k) Third Party ReviewPresentation Printable Slides 510(k) Electronic Submission Pilot ProgramPrintable Slides Transcript De Novo De Novo ProgramPresentation Printable Slides Transcript Clinical Studies/Investigational Device Exemption (IDE) IDE…
Class I Medical Device Recall: Insulet Corporation OmniPod Insulin Management System May Fail to Deliver Insulin
<!– –> <!– Page Last Updated: 09/10/2015 –> Page Last Updated: 09/10/2015 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
MDSAP Mid-Pilot Report, August 2015
%PDF-1.7 % 912 0 obj stream x=]s7rV.O|cRsu/ꪨ”d9U+~i}+”)ߐ{ٙf3+St7쇽7wzlpyޭ.}|{}}O=RLr%fe?̞x+1bv|’tvއt/oώ~|
FDA Voice blog
By: Adam Berger and Zivana Tezak President Obama’s Precision Medicine Initiative (PMI) envisions a day when the specific differences between people – genetic, environmental, lifestyle – will be used to customize the healthcare that we receive. Many of the current efforts toward achieving this goal have focused on analyzing and interpreting a person’s unique genetic…