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Searching Content indexed under Food, Drugs, Healthcare, Life Sciences by Lina R. Kontos ordered by Published Date Descending.
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New Draft Guidance On MR Compatibility For Medical Devices
The U.S. Food and Drug Administration (FDA) has published a new draft guidance titled "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment."
United States
15 Aug 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
Regulator Proposes Reducing Requirements For Radiation-Emitting Products
In a welcome move, on 1 April 2019 the U.S. Food and Drug Administration (FDA) proposed reducing regulatory requirements for a number of radiation-emitting electronic products.
Belgium
26 Apr 2019
5
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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