Kristin Zielinski Duggan

Hogan Lovells

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Latest Posts › Premarket Approval Applications

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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

In the midst of government shutdown, FDA pushes ahead with 510(k) modernization

Thirty-two days into the longest government shutdown in U.S. history, the Food and Drug Administration (FDA or the agency) announced two developments signaling further headway toward advancing its previously reported goal to...more

1/25/2019 / 510(k) RTA , FDA Approval , Federal Budget , Federal Funding , Food and Drug Administration (FDA) , Government Shutdown , Life Sciences , Medical Devices , Pharmaceutical Industry , Premarket Approval Applications , Standard of Review , Trump Administration , US-Mexico Border Wall

Navigating the U.S. FDA regulatory clearance for digital medical devices: the 510(k) and Pre-Cert program

Consumer demand for digital health care devices has soared, and it shows no signs of slowing down. But when bringing these devices to market, companies in the digital health space are confronted with numerous challenges. ...more

9/11/2018 / 510(k) RTA , Certification Requirements , FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Premarket Approval Applications

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