Under RAPS

30 October 2012

Regulators, Industry Discuss Potential Impact of IMDRF

By Alexander Gaffney, RF News Editor

The International Medical Device Regulators Forum (IMDRF) may be the newest global harmonization body, but you wouldn't know it by looking at its membership or its ambitions.The organization, launched [Read More...]

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25 September 2012

As 510(k) Process Evolves, Questions Remain

By Zachary Brousseau, senior manager, communications

The 510(k) premarket notification process provides a clearance pathway for new, low-risk medical devices to be sold in the US by proving to the US Food and Drug Administration (FDA) that a proposed product is substantially equivalent to another, existing, legally marketed device. But the process has come under fire from critics in Congress and others who have called it a “loophole” that allows devices onto the market without putting them through a rigorous approval process. [Read More...]

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5 June 2012

A Conversation With FDA's Human Factors and Accessible Medical Technology Expert

By Zachary Brousseau

The US Food and Drug Administration (FDA) released its Draft Guidance for Industry and Food and Drug Administration Staff—Applying Human Factors and Usability Engineering to Medical Devices to [Read More...]

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