Safety & Risk Management
U.S. FDA Offers Advice on When Product Enhancements Require a Market Recall
Guidance Stresses False-Result Risk Mitigation on Dengue Virus Reagents
U.S. FDA Steps Back on Reporting Requirements for Enhancements
Canada Proposes Stiffer Requirements, Fines to Guard Against Unsafe Devices
Australia Releases Costs, Details of Planned Premarket Reforms
Industry Trans-Tasman Warning System Could Spark Unnecessary Concerns
EU Panel Urges Cautious Approach to Introducing New MoM Implants
SCENIHR Recommends Phased Approach to Risk Evaluation of Nanomaterials
EC Report Calls for Breast Implant Registry, Long-Term Retrieval Study
Report Details Risk Management Needed to Conform to EU’s MDD, Annexes Z
EU Panel Updates Guidance on Safety of Dental Amalgams, Alternatives
EU Panel Urges Cautious Approach to New Metal-on-Metal Prostheses
UK Proposal Would Block Most Metal-on-Metal Hip Implants
MHRA Tells Devicemakers to Balance Risk With Need to Show Efficacy
WHO Wants Measuring Devices to Be Mercury-Free By 2020
Regulators Forum Finalizes Risk-Based Framework for Software as a Device