News

Latest News | 26 April 2013

FDA Looks to Registries and New Adverse Event Reporting Systems to Improve Device Safety

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US medical device regulators may be getting a lot of attention of their new proposals to finalize a unique device identification (UDI) rule, but four other proposals will be critical as well in the US Read More...

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Latest News | 25 April 2013

Program Intended to Clear Path for Easier Medical Device Studies Kept Alive

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The US Food and Drug Administration (FDA) has announced the extension of a pilot program first announced in November 2011 that aims to facilitate early feasibility studies for experimental medical Read More...

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Latest News | 24 April 2013

Final FDA Guidance to Reduce Regulatory Burdens for Updated IVDs

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A new guidance document just published by the US Food and Drug Administration (FDA) is intended to present a "least burdensome regulatory approach" for sponsors of class III in vitro diagnostic Read More...

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Latest News | 18 April 2013

New Regulation Proposes Allowing Device Manufacturers to Use Validated Symbols in Labeling

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The US Food and Drug Administration (FDA) has announced a new regulation that would allow medical device products to use a stand-alone symbol or image on the product's labeling under specific Read More...

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Latest News | 17 April 2013

IMDRF Establishes Groundwork for 'The Future of Regulation' with New Auditing Standards

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New draft guidance documents released by the International Medical Device Regulators' Forum (IMDRF) aim to establish new standards for medical device auditing and monitoring organizations, as well as Read More...

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Latest News | 17 April 2013

Draft IVD Proposal Would Strengthen Clinical Testing Requirements

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A new draft legislative report issued by a member of the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI), Peter Liese, would make significant changes to the Read More...

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Latest News | 17 April 2013

IMDRF Issues Major Guidance Outlining UDI Framework for Medical Devices

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The International Medical Device Regulators' Forum (IMDRF), the regulators-only medical device harmonization group, has released a long-awaited major medical device proposal for industry comment Read More...

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Latest News | 15 April 2013

In Unprecedented Shift, EU Parliament Proposes Premarket Authorization for Medical Devices

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A key member of the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) today issued a draft report that calls for the establishment of a regulatory system that Read More...

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Latest News | 15 April 2013

Identical Problems Prompt Second Major Warning about Diabetes Testing Device in Single Month

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Is there something inherently wrong with most currently-marketed blood glucose meters? Some healthcare industry watchers may be thinking that today, as yet another company has issued a voluntary Read More...

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Latest News | 12 April 2013

FDA Finalizes Guidance on Device Classification Procedures

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The US Food and Drug Administration (FDA) has released a new guidance document finalizing its recommendations for the medical device industry on how to use Classification Product Codes (CPC), a Read More...

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