The Food and Drug Administration may toughen is approval process for 510(k) clearance for medical devices, according to a report by the Wall Street Journal. The move causes concern for medical device ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

House legislators heard arguments over the FDA’s regulatory process, with opposing arguments stating the approval process of medical devices is either too slow or too quick, according to a Washington ...

Americans cannot rely on the Food & Drug Administration (FDA) to guarantee that medical devices are safe, and a recent Government Accountability ...

Americans rely on the Food and Drug Administration to make sure that medical devices are safe. Reporting by KFF Health News has raised questions about how the FDA has dealt with some products, ...

Table I. (click to enlarge) A comparison of different aspects of the U.S., EU, and Japanese medical device markets. Supply factors in the Japanese medical market have contributed to slower approval ...

In her final presentation for health policy class at the University of Chicago, first-year medical student Robin Ji informed her classmates that the Food and Drug Administration does not require ...

Uncovering the dangers associated with a common surgical tool poses a question: Why is the FDA still following a 1976 process that systematically approves devices based on similarity to other devices ...

The "FDA (Food and Drug Administration) Approval Process for Medical Devices Training Course" conference has been added to ResearchAndMarkets.com's offering. This seminar is intended for regulatory, ...

DUBLIN--(BUSINESS WIRE)--The "FDA Approval Process for Medical Devices" conference has been added to ResearchAndMarkets.com's offering. This seminar will provide a solid foundation in the approval and ...