USA – FDA releases draft guidance for non-spinal orthopedic bone fixation devices
The US Food and Drug Administration (FDA) has released a new draft guidance outlining what information should be included in premarket submissions for orthopedic...
USA – FDA updates third party 510(k) guidance
The US Food and Drug Administration (FDA) has published a draft guidance that updates a 2020 final guidance on its third party 510(k) review...
USA – FDA proposes long-awaited LDT enforcement rule
The US Food and Drug Administration (FDA) has published a much-anticipated proposed rule that aims to end its enforcement discretion of laboratory-developed tests (LDT)...
USA – New guidances outline eSTAR submission requirements for de novo and 510(k) device...
The US Food and Drug Administration is one step closer to requiring electronic submission of all premarket applications for both 510(k) and de novo...
USA – FDA advisors want standards, labeling to address racial disparities with pulse oximeters
A panel of external US Food and Drug Administration (FDA) experts are urging more research to improve the efficacy of pulse oximeters in people...
USA – FDA issues final guidance on obtaining informed consent in drug and device...
The US Food and Drug Administration (FDA) on Tuesday announced it has finalized guidance to help institutional review boards (IRBs), clinical investigators, and sponsors...
USA – Experts discuss red flags that can trigger legal action against drug and...
Legal observers discussed some of the red flags that can trigger legal actions against healthcare product manufacturers, as well as some of the lessons...
USA – Opioid use disorder: FDA drafts guidance on clinical considerations for devices
Sponsors of clinical trials of medical devices to treat opioid use disorder (OUD) face “complex challenges,” the US Food and Drug Administration (FDA) said....
USA – FDA updates medical device biocompatibility guidance with exclusion list
The US Food and Drug Administration (FDA) has updated its guidance on biocompatibility issues medical device sponsors should consider in their premarket submissions. This...
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...
