USA – Mirvie’s Preeclampsia Test Designated an FDA Breakthrough Device
South San Francisco, Calif.-based Mirvie has secured the FDA’s Breakthrough Device designation for its test to indicate a woman’s risk of developing preeclampsia during...
USA – EPA proposes rules on EtO with implications for medical device sterilization
The US Environmental Protection Agency (EPA) has proposed two much-anticipated rules that would restrict how much ethylene oxide (also referred to as EO or...
USA – FDA proposes animal study requirements for dental bone grafts
The US Food and Drug Administration (FDA) on Thursday issued draft guidance for sponsors of dental bone grafting devices that offers advice on using...
USA – FDA and CMS: Americans Deserve Accurate and Reliable Diagnostic Tests, Wherever They...
Physicians heavily rely on laboratory tests to make critical decisions about their patients’ care—roughly 70% of healthcare decisions depend on laboratory test results according...
USA – FDA updates guidance on remote regulatory assessments
The US Food and Drug Administration (FDA) has revised its draft guidance on remote regulatory assessments (RRAs), outlining how it plans to use both...
USA – FDA proposes guidance on orthopedic product coatings
The US Food and Drug Administration (FDA) wants orthopedic device sponsors to provide additional data in their premarket application if their product has a...
USA – FDA criticized for approval of genetic test for opioid addiction risk
Physicians and public health advocates are urging the US Food and Drug Administration (FDA) to revoke its approval of AvertD to predict the potential...
USA – Legal expert: FDA’s CDS software guidance is a ‘disaster’ for industry
The US Food and Drug Administration’s (FDA) final guidance on clinical decision support (CDS) software goes against the statutory language laid out in the 21st Century...
USA – Best Practices for Selecting a Predicate Device to Support a Premarket Notification...
FDA developed this document to provide guidance to industry and FDA staff about best practices in selecting a predicate device for premarket notification ...
USA – Experts call for data transparency with recalled medical devices
Over the last few years, some patients have been receiving implantable cardioverter-defibrillators (ICDs) that are subject to Class I recalls. These devices have continued...
