FDA seek to harmonize human subject protections with revised Common Rule
The US Food and Drug Administration (FDA) on Tuesday issued two proposed rules aimed at harmonizing certain sections of the agency’s regulations on human...
USA – Studies linking recalled 510(k) devices to problematic predicate products are ‘warning shot’...
Two recent studies that link the recall of 510(k)-cleared medical devices to problematic predicate products should serve as a “shot across the bow” for...
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 – FDA issues roadmap to medical device regulatory guidance topics list for 2023
The US Food and Drug Administration has released a list of guidance documents it plans to issue over its 2023 fiscal year. FDA’s Center...
USA – FDA releases draft guidance for non-spinal orthopedic bone fixation devices
The US Food and Drug Administration (FDA) has released a new draft guidance outlining what information should be included in premarket submissions for orthopedic...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 finalizes guidance on machine learning for medical devices
The US Food and Drug Administration has finalized guidance on the regulation of software as a medical device (SaMD) that utilizes artificial intelligence or...
USA – Theranos : onze ans de prison contre Elizabeth Holmes, patronne déchue, condamnée...
L’ancienne star de la Silicon Valley Elizabeth Holmes, reconnue coupable de fraude en janvier, a été fixée sur sa peine, vendredi 18 novembre, près de...
USA – Diversity plan draft guidance on track before year end, FDA official says
The US Food and Drug Administration (FDA) is on track to publish a draft guidance on diversity plans before year’s end, which will take...
USA – Remote regulatory assessments: Pharma, device groups want more details on FDA guidance
Trade groups representing the pharmaceutical and medical device industries, while largely supporting the use of remote regulatory assessments (RRAs) as outlined in the US...
USA – Advocacy groups, AdvaMed vie for next phase of TAP pilot
Medical devices that treat brain diseases and disorders should be the next products to be accepted into a US Food and Drug Administration (FDA)...
