Pharmacy Times June 29, 2022
Companies, FDA caught unaware by surge in virus cases, leading to shortage of critical items.
From adhesive bandages to heart monitors, medical devices are all around us. Some of these are easily accessible in stores, whereas others are exclusive to clinics and hospitals. How is it possible to determine which medical devices are effective and safe for use with patients?
The current process for approving medical devices is administered by the FDA. The FDA oversees the premarket audit, clearance, and approval process by sorting the medical devices into 3 classes based on risk level. Traditionally, this process has been effective and efficient enough. However, with the COVID-19 outbreak, there have been issues with delays and shortages of vital medical devices,...
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