Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...

The Food and Drug Administration ... While older devices already in use won't be affected immediately, manufacturers seeking approval for updates or modifications will need to comply with the ...

The future of medical devices has much potential, but they also have risks related to cybersecurity. In 2024, we saw the first full year of the Food and Drug Administration’s (FDA) new guidance ...

The Food and Drug Administration Feb. 5 released an alert notifying patients of a safety concern using diabetes devices such ...

While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are having greater impacts on the smallest patients—including in neonatal ...

“The FDA strongly supports advancing innovative animal biotechnology products that are safe for animals, safe for people, and achieve their intended results.” Pigs with the genetic modification are ...

The draft guidance provides insights on how FDA plans to apply total product life cycle (TPLC)[1] principles that have historically applied to traditional hardware medical devices and artificial ...

Some products bought in pharmacies, including tampons and adhesive bandages, are listed as “medical devices” in Taiwan and may not be resold, the Food and Drug Administration (FDA) said yesterday.

Existing devices already on the market will not need to meet these new standards unless manufacturers request updates or modifications. The FDA will accept public comments on the draft proposal ...