Kristin Zielinski Duggan

Hogan Lovells

+ Follow Contact

Latest Posts › FDA De Novo Clearance

Share:

FDA launches list of AI and machine learning-enabled medical devices

Yesterday, the U.S. Food and Drug Administration (FDA) shared online its list of artificial intelligence and machine learning (AI/ML)-enabled devices that are legally marketed in the U.S. (via 510(k) clearance, De Novo...more

9/24/2021 / Artificial Intelligence , Digital Health , FDA De Novo Clearance , Food and Drug Administration (FDA) , Machine Learning , Medical Devices , Premarket Approval Applications

Uncertainty remains: FDA releases new benefit-risk decision tree for medical device PMAs and De Novos in concert with final...

On 30 August 2019 the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance document entitled "Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals,...more

9/6/2019 / FDA Approval , FDA De Novo Clearance , Final Guidance , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Premarket Approval Applications

CDRH issues final rule on appeals, excluding De Novos from 517A

On 2 July 2019 the U.S. Food and Drug Administration (FDA) issued a final rule finalizing the category of "517A decisions," previously termed "significant decisions," as well as two accompanying guidance documents related to...more

7/10/2019 / Administrative Appeals , FDA De Novo Clearance , Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , Medical Devices , Rulemaking Process

3 Results

View per page

Page: of 1