<!– –> <!– Page Last Updated: 12/28/2016 –> Page Last Updated: 12/28/2016 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français |…
FDA Voice blog: Managing Medical Device Cybersecurity in the Postmarket: At the Crossroads of Cyber-safety and Advancing Technology
By: Suzanne B. Schwartz, M.D., M.B.A. Protecting medical devices from ever-shifting cybersecurity threats requires an all-out, lifecycle approach that begins with early product development and extends throughout the product’s lifespan. Today, we’re pleased to announce that industry now has advice from FDA across this product continuum with the release of a final guidance on the…
Public Workshop
The Food and Drug Administration (FDA), is announcing the following public workshop entitled “Coordinated Registry Network (CRN) for Devices Used for Acute Ischemic Stroke Intervention (DAISI).” The purpose of the public workshop is to obtain stakeholders’ input on the coordination of registries for Devices Used for Acute Ischemic Stroke Intervention. FDA is soliciting input on…
Webinar – Postmarket Management of Cybersecurity in Medical Devices Final Guidance
<!– –> <!– Page Last Updated: 12/27/2016 –> Page Last Updated: 12/27/2016 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français |…
Health Industry Business Communications Council (HIBCC) Issuing Agency Accreditation Extension Letter
%PDF-1.5% 40 0 objendobj 58 0 obj/Filter/FlateDecode/ID[]/Index[40 35]/Info 39 0 R/Length 88/Prev 45605/Root 41 0 R/Size 75/Type/XRef/W[1 2 1]stream hbbd“b`S@D5`_S3/6 bHQ@QHb`bdd100RNg
Postmarket Management of Cybersecurity in Medical Devices
%PDF-1.7 % 2089 0 obj stream xy`}s@Hr @=0E9 Qx”TEAV!(g
Potential Problems with Battery-Powered Mobile Medical Carts in Health Care Facilities that May Result in Fire: Letter to Health Care Professionals
December 27, 2016 Dear Health Care Professionals, Health Care Facility Administrators The FDA is warning health care facilities of potential safety risks associated with battery-powered mobile medical carts. The FDA is aware of reports of explosion, fires, smoking, or overheating of equipment that required hospital evacuations associated with the batteries in these carts. ANALYSIS OF…
Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions
%PDF-1.7 % 1948 0 obj stream xa*E]KP )aJH *%RJH 7vaA^_y }~
CDRH Fiscal Year 2017 (FY 2017) Proposed Guidance Development and Focused Retrospective Review of Final Guidance
Introduction Why is CDRH posting lists of guidance documents it intends to issue? Does CDRH expect to complete the A-list and B-list? Why is CDRH posting a list of guidance documents as part of its retrospective review? How do I comment on these lists or a particular guidance document? What guidance documents is CDRH considering…
Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150022, DEN150038, DEN150057 added)
<!– –> <!– Page Last Updated: 12/22/2016 –> Page Last Updated: 12/22/2016 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français |…