HealthDay News — Although most manufacturer reports of medical device adverse events are reported on time, a considerable proportion are submitted late, according to a study published online March 12 ...
A new study found that 9.1% of medical device AEs were reported to the FDA 180 days later than required over a three-year ...
The National Association of Boards of Pharmacy (NABP) plays an important role in the state licensing of prescription medical device manufacturers ...
As momentum continues to build, medical device companies are ramping up their investment in 3D printing technology. Driven by ...
The global Medical Device Contract Manufacturing market size was $73.61 billion in 2023 and is projected to reach $81.19 billion in 2024. This market is expected to grow significantly, reaching ...
Over 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) within the deadline set by federal regulations, finds an analysis of recent data ...
A manufacturer produces a medical device for physicians to use to administer a particular type of treatment to their patients ...
Objective To describe the extent of late adverse event reporting by manufacturers to the US Food and Drug Administration’s (FDA) Manufacturer And User Facility Device Experience (MAUDE) database as ...
The FDA stated that its published medical device cybersecurity requirements from 2023 do include AI in a broad sense. However ...