New Items | Sent out each business day. Contains a list and links to items added to the CDRH website on the previous business day. | |
Breast-Implants | Information about upcoming events, panel meetings, and safety information associated with breast implants. | |
CDRH Science | Updates on regulatory science, the science of developing new tools, standards and approaches to assess the safety, efficacy, quality, and performance of medical devices and radiation-emitting products. | |
CDRH Transparency | In support of the FDA Transparency Initiative, CDRH is providing additional information to help the public understand its processes and decisions. | |
Contact Lenses | Contact lens safety news and information about the latest innovations in contact lenses. | |
eMDR – electronic Medical Device Reporting | The electronic Medical Device Reporting (eMDR) project provides the capability for electronic data entry and processing of medical device adverse event reports. | |
Event Problem Codes | Updates on enhanced device and patient problem codes that will be going live July 1, 2009. The FDA has provided this information in advance to help you familiarize yourselves with Event Problem Code updates BEFORE the new codes "go live" and are accepted in MAUDE. | |
FDA Patient Safety News | This mailing list notifies subscribers when new programs in the FDA Patient Safety News series are available for viewing. FDA Patient Safety News is a televised series for health care personnel featuring information on new drugs, biologics and medical devices, on FDA safety notifications and product recalls, and on ways to protect patients when using medical products. | |
FDA Radiological Health Program | News about radiological products and procedures regulated by FDA, and FDA’s role in radiation safety. | |
Mammography | A mailing list that announces new mammography documents and updates to the CDRH/Mammography Web Site. | |
Medical Device Epidemiology Network Initiative | Mailing list for the Medical Device Epidemiology Network Initiative (MDEpiNet), a collaborative program through which CDRH and external partners share information and resources to enhance our understanding of the safety and effectiveness of medical devices after they are marketed. | |
Medical Device Recalls | Notices about Class I medical device recalls and some Class II and III recalls of interest to consumers. | |
Medical Device Safety | Updates for health care professionals on device recalls, Public Health Notifications, and other safety information. | |
MedSun – Medical Product Safety Network | The Medical Product Safety Network (MedSun) improves FDA’s understanding of problems with the use of medical devices so that the FDA, healthcare facilities, clinicians, and manufacturers can better address safety concerns. | |
Office of In Vitro Diagnostics | Updates on 510(k) decision summaries, Turbo 510(k) eSubmissions, guidance documents, and upcoming meetings and presentations about in-home and laboratory diagnostic tests. | |
Personal Protective Equipment | Information about personal protective equipment (PPE) regulated by FDA for use in patient care. | |
Recent Device Approvals | Information about medical devices FDA has recently approved. | |
Registration & Listing | Registration and listing provides FDA with the location of medical device establishments and the devices manufactured at those establishments. | |
Reprocessing of Single-Use Devices | Information about the reprocessing of single-use medical devices (SUDs). | |
Unique Device Identification | Information on how the use of a Unique Device Identification (UDI) system may improve patient safety. | |