The FDA’s New Guidance on Wireless Devices

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Description:

The U.S. FDA has just published their long-anticipated Unique Device Identification System Final Rule, on September 23, 2013. It’s purpose is to “establish a system to adequately identify devices through distribution and use.” It requires the development of a unique device identifier (UDI) in plain text and machine readable formats, to be part of the labeling of every medical device. There is an 4+ year phase in depending upon the risk / class of the device. In addition, the four key steps to compliance by device manufacturers will be addressed. The Final Rule also has provisions to address existing FG inventory, not properly labeled.

The FDA intends for the UDI to facilitate improve device visibility through distribution to patient use, to aid in adverse events reporting, resolution and trending, commonality of nomenclature in clinical information systems, registries, electronic health records, and similar.

This is a major change for medical device manufacturers, with far-reaching effects in regulatory compliance, as envisioned by the FDA. Our instructor, John E. Lincoln has also just completed an article on UDI to be published in an upcoming journal article.

Areas to be Covered:

This Final Rule focuses on two core elements, as will this webinar (in-depth)
The UDI code, consisting of the DI, device identifier, and the PI, production identifiers (UDI = DI + PI), types of acceptable formats, and its use on device labeling
The FDA-administered Global Unique Device Identification Database (GUDID)

Who will Benefit:

This webinar will provide valuable information to all regulated medical device companies that are or anticipate selling devices in the U.S. Its principles apply to Personnel / Companies primarily in the Medical Devices fields. The employees who will benefit include:
Senior management
Middle management
R&D
Engineering
Software
QA / RA
Manufacturing
Operators
Consultants
CGMP instructors
Device Design Team
Device Development Team
Device Manufacturing Team
Verification and/or Validation planning, execution and documentation for devices

John E. Lincoln

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.

He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.

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  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance