Made With Uberflip Content Marketing

FDA / Industry Updates

  • 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.

    Read Blog
  • 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.

    Watch Video
  • 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.

    Watch Video
  • 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.

    Read Blog
  • 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

    Watch Video
  • 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.

    Read Blog
  • 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.

    Read Blog
  • 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.

    Watch Video
  • 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.

    Read Blog
  • 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.

    Read Blog
  • 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?

    Read Blog
  • 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...

    Read Blog
  • 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...

    Read Blog
  • 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...

    Read Blog
  • UDI in Europe and EUDAMED

    UDI in Europe and EUDAMED

    In 2013, the European Commission recommended working toward a harmonized European standard for a unique device identification (UDI) system for medical devices. Since then, regulators and industry...

    Read Blog
  • 50 Days Before I/LS/LS UDI Compliance Date

    50 Days Before I/LS/LS UDI Compliance Date

    Although the FDA recently extended the compliance date for the submission of Implantable, Life-Supporting and Life-Sustaining device UDI records by one month to October 24, 2015, that leaves just...

    Read Blog
  • FDA UDI System Status Update: Full Functionality Restored

    FDA UDI System Status Update: Full Functionality Restored

    The FDA announced today that it has restored full functionality for the GUDID. This means that the Pre-production and Production environments of the FDA Web Interface are once again available for...

    Read Blog
  • 2015 UDI Compliance Date Extended

    2015 UDI Compliance Date Extended

    The FDA has recently issued a guidance document stating that it is extending the compliance date for Implantable, Life-Supporting and Life-Sustaining devices one month to October 24, 2015. This...

    Read Blog
  • FDA UDI System Status Update: SPL Functionality Restored

    FDA UDI System Status Update: SPL Functionality Restored

    On Wednesday, the FDA announced it was taking the GUDID Production and Pre-production environments offline due to a security vulnerability while a software patch was being developed. We are very...

    Read Blog
  • FDA UDI System Status

    FDA UDI System Status

    The FDA announced this morning that it has identified a security vulnerability in its UDI database system, GUDID. While a patch to fix the vulnerability is being developed, the FDA has decided to...

    Read Blog
  • loading
    Loading More...