Making Sense of IVD Regulation - Webinar Recording/Transcript

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Making Sense of IVD Regulation: IVDs, LDTs, RUOs, IUOs, ASRs, or GPRs — Are You Following the Right Rules?

Devicemakers, IVD marketers and clinical labs struggle often with FDA regulation — and it’s no wonder. The rules governing IVDs are scattered throughout the CFRs , and exceptions, special cases and pitfalls abound. Some hapless firms have even followed the wrong set of rules — and endured 483s or warning letters as a result.

FDAnews has called upon one of its most popular presenters, Dan O’Leary of Ombu Enterprises, to clear up the confusion.

Mr. O’Leary combed through the CFR for every reference to IVDs, then reorganized them by topic for greater clarity. His worksheet is the basis for a presentation that will bring new understanding to one of the murkiest areas of FDA regulation.

In just 90 minutes, you will:

  • Learn technical definitions of  IVDs, LDTs, RUOs, IUOs, ASRs, and GPRs
  • Learn practical definitions of these terms
  • Understand the distinction between “finished devices”, “investigational products”, and “research products”
  • Learn the pre-market submission paths, if needed, for these devices
  • Understand the labeling requirement for these devices
  • Understand when laboratories must include specific information on their reports
  • Understand restrictions on sale to specific parties
  • And much more!

Special FREE bonus: Participants receive their own copy of Mr. O’Leary’s worksheet, a benefit that could be worth the registration fee by itself.

Don’t count on the FDA to help you make sense of IVD regulation. Guidance documents are few and far between, and new ones are not expected any time soon. This presentation is your opportunity to clear up regulatory confusion. Don’t risk a Form 483, a warning letter or worse.

IVD regulation cuts across many FDA-regulated industries. This webinar is for the IVD and lab communities as well as others affected by this confusing area of FDA rulemaking:

  • Quality Managers of IVD manufacturers
  • Lab Directors who use ASRs
  • Lab Directors who perform High Complexity Testing under the CLIA regulations
  • Regulatory Managers of IVD manufacturers
  • Sales Managers of IVD manufacturers
  • Compliance Managers of IVD manufacturers
  • Compliance Managers of High Complexity labs

Dan O’Leary is President of Ombu Enterprises LLC, a company offering training and execution in Operational Excellence via a systems approach to operations management. Mr. O’Leary boasts more than 30 years’ experience in quality, operations, and program management in regulated industries including medical devices, clinical labs, aviation and defense. He is an ASQ-certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.