FDA fights EpiPen shortage by extending expiration date for some devices
August 21, 2018
By Neozene

The FDA took steps Tuesday to mitigate the shortage of EpiPens by allowing some expired devices for treating life-threatening allergic reactions to remain on the market. The FDA said that after reviewing data, it had decided it can extend the expiration date by four months for specific lots of EpiPens that are expired or close to expiring. “Many patients rely on self-injectable epinephrine products, such as EpiPen, to reverse life-threatening reactions to bee stings or other allergens for either themselves or for their children. We are doing everything we can

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Global Medical Device Regulatory Trends: Traceability, Simplified Market Access
July 31, 2018
By Neozene

In the past half year (January through June 2018), Emergo has observed data to support two global trends: Initiatives to enhance device tracking and traceability, and simplification of the regulatory process for the lowest-risk medical devices. Periodically, we review all the global regulatory updates and changes for global trends. These are Emergo’s observations, fueled only by review of regulatory current events (and perhaps a few large cups of coffee). And, our analysis and assessment of them. We should also acknowledge that the International Medical Device Regulators Forum (IMDRF) has been working

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US Regulators Propose Expanded Medical Device Cybersecurity Approach
May 1, 2018
By Neozene

The US Food and Drug Administration is considering several new measures to address medical device safety and cybersecurity, including a new public-private coordinating board to evaluate high-risk, high-impact connected devices. The cybersecurity and related measures make up the agency’s new Medical Device Safety Action Plan, developed to focus also on issues including streamlined post-market processes; foster innovation to boost device safety; and merge the Center for Devices and Radiological Health’s (CDRH) premarket and post-market branches to advance a “Total Product Lifecycle” or TPLC approach to device evaluation and oversight. Cybersecurity

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