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Searching Content by Kristin Zielinski Duggan from Hogan Lovells ordered by Published Date Descending.
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Uncertainty Remains: FDA Releases New Benefit-Risk Decision Tree For Medical Device PMAs And De Novos In Concert With Final Uncertainty Guidance
On 30 August 2019 the U.S. Food and Drug Administration issued a final guidance document entitled "Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals.
United States
9 Sep 2019
2
FDA Details Recommendations For Live Case Presentations During Medical Device Clinical Trials In Final Guidance
This month, the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance on live case presentations as part of clinical trials
United States
31 Jul 2019
3
CDRH Issues Final Rule On Appeals, Excluding De Novos From 517A
On 2 July 2019 the U.S. Food and Drug Administration (FDA or the agency) issued a final rule1 updating the processes for appeal of certain FDA decisions related to medical devices regulated
United States
18 Jul 2019
4
An Intelligent Approach For Regulating Medical Device AI
Hogan Lovells has been at the forefront of advising our clients on the clearance or approval of an increasing number of software as a medical device products and other medical devices that incorporate AI/ML algorithms
United States
22 Apr 2019
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