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Podcast: Talking the cure
11 April 2024
Our team is always thinking about how to foresee and conquer the most significant industry issues facing our clients. In 2020, we launched the podcast "Talking the Cure" where we cover...
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FDA spells out electromagnetic compatibility info needed in medical device premarket submissions
21 June 2022
The U.S. Food and Drug Administration (FDA) recently issued the final guidance, “Electromagnetic Compatibility (EMC) of Medical Devices: Guidance for Industry and Food and Drug...
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FDA finalizes guidance on non-clinical assessment of medical devices containing nitinol
27 October 2020
The U.S. Food and Drug Administration (FDA) has finalized their guidance related to medical devices that contain nitinol, the draft of which was published on April 19, 2019. The guidance...
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New draft guidance on MR compatibility for medical devices
13 August 2019
The U.S. Food and Drug Administration (FDA) has published a new draft guidance titled "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment."
News
New draft guidance on MR compatibility for medical devices
12 August 2019
The U.S. Food and Drug Administration (FDA) has published a new draft guidance titled "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment."
News
FDA proposes to expand abbreviated 510(k) pathway for certain devices
19 April 2018
Building on recent efforts to streamline premarket review of medical devices, on April 12, 2018, the Food and Drug Administration (FDA) issued a draft guidance seeking to expand use of the...
News
FDA proposes to expand abbreviated 510(k) pathway for certain devices
18 April 2018
Building on recent efforts to streamline premarket review of medical devices, on April 12, 2018, the Food and Drug Administration (FDA) issued a draft guidance seeking to expand use of the...
