FDAnews Announces — New Direct Marking Requirements for UDIs: How to Comply with the Final Guidance Webinar, March 6, 2018

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In a 90-minute presentation, Jay Crowley, a 27-year veteran of the FDA, will take apart the final guidance on UDIs in non-technical language, with the focus on what devicemakers need to know.

New Direct Marking Requirements for UDIs:
How to Comply with the Final Guidance
**An FDAnews Webinar**
March 6, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/newdirectmktgrqrmntsudis    

The FDA has handed devicemakers a high-stakes puzzle:

  • Classify products correctly under the final UDI guidance, issued in November
  • Or get something wrong and face threats that range from 483s and warning letters, to patient harm and liability judgments

But doing things right won’t be easy. High-priced lawyers already are hard at work parsing what the final guidance actually says about direct marketing of Class I, Class II and unclassified devices. With full compliance for Class II devices just months away, there’s not much time left to figure things out.

It’d be great to find out what the FDA was actually thinking when it put together that final guidance.

Mark the calendar for Tuesday, March 6, when the architect of the UDI tells all.

Jay Crowley, a 27-year veteran of the FDA, was patient safety advisor to the
CDRH until 2014, when he joined the regulatory consulting firm USDM Life Sciences as vice president of its unique device identification (UDI) practice. “There is nobody more qualified to help our medical device clients become UDI compliant than the person who developed the FDA’s compliance rules,” his new employer asserts.

In a 90-minute presentation, Mr. Crowley will take apart the final guidance in non-technical language, with the focus on what devicemakers need to know. Prepare to discover:

  • How the definition of “intended to be reprocessed” for purposes of UDI direct marking has changed from draft to final rule (it now identifies which devices are subject to the additional direct marking requirement)
  • Whether “single patient use” devices, ones which the patient reprocesses, fall under the direct mark requirement
  • What the final guidance says about how consigned or loaned devices will be treated for the purposes of the direct mark requirement
  • How long the FDA believes the direct mark UDI should last
  • How the existing-inventory exception affects those devices also subject to the direct mark requirement
  • FDA recordkeeping requirements for devices that must be directly marked
  • And much more!

Full compliance is looming. (Sept. 24, 2018, for Class II devices; Sept. 24, 2020, for Class I and unclassified devices.) Now is the time to sort out the likely impact of this key regulatory action.

Meet the Presenter:
Jay Crowley, former Senior Advisor for Patient Safety in FDA’s Center for Device and Radiological Health, is now Vice President, Unique Device Identification Services and Solutions, at USD Life Sciences. At the FDA he developed the framework and authored key requirements for the agency’s Unique Device Identification (UDI) system. “There is nobody more qualified to help our medical device clients become UDI compliant than the person who developed the FDA’s compliance rules,” Crowley’s new employer asserts.

Who Will Benefit:

  • Regulatory affairs
  • Design engineers
  • Labeling specialists
  • Project managers
  • QA/QR/QC
  • Quality Engineers
  • Executive suite
  • R&D
  • Strategic Planning Staff

Webinar Details:
New Direct Marking Requirements for UDIs:
How to Comply with the Final Guidance
**An FDAnews Webinar**
March 6, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/newdirectmktgrqrmntsudis    

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/newdirectmktgrqrmntsudis                                                                                        
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
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