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Category: Medical Device Industry


FDA Finalizes Guidance on Emerging Signals

Nearly a year after the draft was issued, the Food and Drug Administration (FDA) has finalized guidance on emerging signals – when a potential problem with a medical device already on the market could alter the benefit-risk assessment among patients and their healthcare providers.

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21st Century Cures Act Calls for 21st Century Recall Preparation

The 21st Century Cures Act has cleared a major Senate hurdle and is expected to be signed into law by President Obama. Among other provisions, the bill will fast-track the approval process for certain drugs and medical devices. The $6.

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Adverse Event Reporting Delays: Another Issue with Data

Medical device manufacturers learn about potential defects from a variety of sources, including healthcare professionals and patients themselves. But despite mandatory reporting requirements, a dozen hospitals were recently cited by the Food and Drug Administration (FDA) for not reporting information of a potential problem with a device in a timely manner.

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Secondhand Medical Device Safety: FDA Seeking Feedback

As it stands, effectively resolving any recall can be difficult. Some medical device manufacturers have expressed concern to the Food and Drug Administration (FDA) that this process could be made more challenging as potentially unqualified personnel “refurbish, recondition, rebuild, remarket, remanufacturer, service, and repair” devices. This sentiment was echoed in a recent

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The Promise – and Potential Pitfalls – of 3D Printing

From guitars to light fixtures to mechanical parts, 3D printing is growing rapidly. It’s a technology that holds a lot of promise in many fields, including the pharmaceutical and medical device industries. 3D printing could offer several advantages for manufacturers and patients alike. In many cases, it could be easier to create devices specifically designed for individual patients. Devices and medications meant for the masses could be produced faster and at less cost than traditional methods.

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