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FDA / Industry Updates

  • NHS eProcurement Q&A19:55

    NHS eProcurement Q&A

    Gary Saner and John Lorenc respond to questions submitted during a recent webinar on NHS eProcurement. Submit your questions to MedDevice@ReedTech.com

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  • NHS eProcurement Requirements, Timelines and Strategies50:51

    NHS eProcurement Requirements, Timelines and Strategies

    Join Gary Saner and John Lorenc of Reed Tech for a discussion of the UK National Health Service's eProcurement requirements and how affected medical device labelers can comply.

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  • UK NHS eProcurement: The What, Who, Why and When

    UK NHS eProcurement: The What, Who, Why and When

    eProcurement is a requirement for any organization doing business with an NHS care provider. For most device companies operating in the U.K., NHS is by far the largest customer in that market.

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  • Why the FDA Extended the Class I UDI Deadline (and What the Delay Means for You)

    Why the FDA Extended the Class I UDI Deadline (and What the Delay Means for You)

    FDA’s Class I extension is about ensuring GUDID data quality and submission accuracy, not about giving industry time to work on other projects.

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  • Structured Product Labeling, Eh? Health Canada’s SPL Pilot

    Structured Product Labeling, Eh? Health Canada’s SPL Pilot

    Health Canada is working with volunteer manufacturers and sponsors, as well as technology vendors, to test the application of the HL7 SPL standard to the content of drug product monographs.

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  • FDA Insight: UDI Data Quality

    FDA Insight: UDI Data Quality

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  • UDI Update: New FDA GUDID Technical Documents Released

    UDI Update: New FDA GUDID Technical Documents Released

    FDA sent an email to its list of UDI GUDID email subscribers with updated GUDID Data Elements Reference Table and GUDID HL7 SPL Implementation Files.

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  • UDI Post-GUDID Publishing Webinar1:00:16

    UDI Post-GUDID Publishing Webinar

    UDI expert John Lorenc of Reed Tech examines post-submission UDI data maintenance and data management responsibilities and strategies.

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  • REMS in SPL Webinar1:03:44

    REMS in SPL Webinar

    SPL expert Gary Saner discusses the FDA's new initiative to receive Risk Evaluation and Mitigation Strategy (REMS) submissions in Structured Product Labeling format.

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  • 4 Reasons to Submit REMS in SPL Now

    4 Reasons to Submit REMS in SPL Now

    Some industry members may question whether REMS in SPL is worth the effort, since SPL is not yet mandated for REMS. Here are four great reasons to get start submitting REMS in SPL now.

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  • FDA Drug Establishment Site Registration Webinar31:30

    FDA Drug Establishment Site Registration Webinar

    SPL subject matter expert Jon Nolan gives an overview of the FDA's requirements for registering Drug Establishment sites. Learn More: http://www.reedtech.com/products-services/life-sciences/structur

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  • Drug Establishment Registration Reporting Requirements and Timelines

    Drug Establishment Registration Reporting Requirements and Timelines

    Every electronic drug establishment registration must be renewed or updated annually between October 1 and December 31, regardless of whether there have been changes to the data.

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  • Time is Up! Class II UDI Deadline Tomorrow

    Time is Up! Class II UDI Deadline Tomorrow

    For those of us who have been working on UDI for months or years, it may seem hard to believe that tomorrow is already the FDA’s Class II UDI compliance date.

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  • UDI Q&A with Jay Crowley and Gary Saner1:01:48

    UDI Q&A with Jay Crowley and Gary Saner

    On September 8th, 2016, UDI experts Jay Crowley (USDM) and Gary Saner (Reed Tech) took questions live from industry members working to meeting the September 24 deadline for Class II medical devices.

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  • FDA UDI Class II Extension: Does it apply to your products?

    FDA UDI Class II Extension: Does it apply to your products?

    This week, the FDA issued a letter extending the UDI labeling and data submission compliance date to 2018 for certain categories of Class II devices.

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  • FDA now accepting REMS in SPL format

    FDA now accepting REMS in SPL format

    Submission of REMS in SPL will help to clarify and standardize REMS content across the industry, making FDA review procedures more efficient.

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  • Just 25 Business Days Remaining Before the Class II UDI Deadline!

    Just 25 Business Days Remaining Before the Class II UDI Deadline!

    If your company markets Class II devices in the U.S., have you successfully submitted your UDI records to the FDA? If not, are you on the path to full compliance within the next 25 business days?

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  • UDI Exceptions, Exemptions and Extensions

    UDI Exceptions, Exemptions and Extensions

    As the September 24 deadline approaches, a growing number of Class II labelers have been asking whether their devices might be somehow exempt from UDI requirements, or if at the FDA might grant...

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  • FDA UDI Enforcement: 4 Things to Consider

    FDA UDI Enforcement: 4 Things to Consider

    While recently speaking with a regulatory manager who works at a medical device manufacturer with a large Class II product portfolio, I was surprised to hear that his organization was not...

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  • UDI Submission Load Testing

    UDI Submission Load Testing

    As I talk to medical device industry members about their plans for UDI, I continue to find many organizations that have not yet begun making their submissions to the GUDID. A lot of labelers have...

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