The Medical Futurist
JUNE 21, 2025
Running trials in animals will take additional engineering and safety tests. In February 2017, experts at the Center for Genome Engineering, within the Institute for Basic Science (IBS) reported the use of CRISPR in performing “gene surgery” in the layer of tissue that supports the retina of living mice.
FDA Law Blog
FEBRUARY 19, 2024
Loloei also served as a Senior Policy Advisor in CDRH and as a Special Advisor in the Office of the Commissioner. Loloei graduated magna cum laude , with a degree in Biomedical Engineering with a concentration in Electrical Engineering from The George Washington University. While at FDA, Ms. During her FDA tenure, Ms.
FDA Law Blog
FEBRUARY 22, 2023
In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. Consider this scenario: A manufacturer files a 510(k) for a Class II device, a surgical mask.
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