WHO to Develop Essential Diagnostics List
The World Health Organization is developing an Essential Diagnostics List to help countries create their own national lists of essential diagnostic tests and tools. Read More
CBO Estimates User Fee Reauthorization Would Require $740 Million
The Congressional Budget Office officially scored the Senate package to reauthorize the FDA’s user fee agreements with the medical device and… Read More
Devices News
New Zealand Updates Device Standards
New Zealand’s Ministry of Health released new standards that will ensure all medical devices are properly named and identified for clinical and supply chain purposes in the country. Read More
Pathways Can Shorten Devicemakers’ Road to Approval
Devicemakers looking to speed their products through the development process can get help from three lesser-known FDA pathways, according to two experts. Read More
Australian Parliament Passes New Device Reforms
Both houses of the Australian Parliament passed new reforms contained in the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016. Read More
483 Roundup: Four Devicemakers Cited for Inadequate Procedures
The FDA issued Form 483s to Jensen Industries, Tyson Bioresearch, OsteoSymbionics and Innovative Sterilization Techniques, citing problems with their procedures for corrective/preventive actions, complaints and MDRs. Read More