News

Latest News | 14 June 2013

AdvaMed Outlines Wishlist for New Changes to 510(k) Process

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The system by which most medical devices reach the market, known as the premarket notification or 510(k) process, has been subject to a considerable amount of criticism in recent years, with Read More...

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Latest News | 13 June 2013

FDA Guidance Sets Up Voluntary New IDE Submission Process Aimed at Correcting Deficiencies

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US regulators today released a new draft guidance document that looks to clarify the US Food and Drug Administration's (FDA) expectations when it comes to approving an investigational device exemption Read More...

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Latest News | 13 June 2013

FDA to Soon Block Approval of Applications With Insufficient Deterrents to Hacking

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The US Food and Drug Administration (FDA) today released a major guidance document regarding security standards for medical device products, a response, FDA said, to increasing concerns about emerging Read More...

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Latest News | 10 June 2013

Device Groups Say FDA Communication Guidance Gets Additional Information Letters Wrong

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Several entities within the medical device industry are calling attention to a provision within a recent draft guidance published by the US Food and Drug Administration (FDA) that they say offers Read More...

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Regulatory Update | 7 June 2013

UK’s MHRA Proposes Tracking System for High Risk Devices

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The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced that four National Health Service hospitals have agreed to pilot a new tracking system for high risk medical devices.  Read More...

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Latest News | 7 June 2013

FDA Again Leverages Emergency Use Authority, Seeking to Stay Ahead of Deadly Mystery Virus

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For the second time in as many months, US regulators have leveraged new authority granted to them under recently-passed anti-bioterrorism legislation that allows them to approve products based on an Read More...

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Latest News | 3 June 2013

Hamburg: Lab-Developed Tests to be Subject to Heightened Scrutiny under New Framework

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For years, the US Food and Drug Administration (FDA) has provided leeway to a sub-category of diagnostic tests known as laboratory-developed tests, or simply LDTs. But according to FDA Commissioner Read More...

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Latest News | 31 May 2013

Medical Device Industry Comes Together to Slam Proposed Regulation on Clinical Trials

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The medical device industry is none too pleased with a proposed regulation released in February 2013 that would require all companies to make sure their clinical trials, no matter where in the world Read More...

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Latest News | 29 May 2013

Blood Supply to Benefit from New RFID-Based Tracking System Cleared by FDA

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When it comes to medical devices, some of the biggest approvals by the US Food and Drug Administration (FDA) in recent months have been for the smallest devices. Now the agency has announced the Read More...

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Latest News | 22 May 2013

FDA Sends Unusual Letter to Maker of iPhone-Based Testing Product

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US regulators regularly send letters to industry regarding alleged transgressions, deficiencies and faults. The most common ones are well-known to the industry: Form 483s outline deficiencies found Read More...

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