Falls Church, VA (PRWEB)
September 28, 2017
Making Sense of IVD Regulation:
IVDs, LDTs, RUOs, IUOs, ASRs, or GPRs — Are You Following the Right Rules?
**An FDAnews Webinar**
Oct. 19, 2017 — 1:30 p.m. – 3:00 p.m. ET
IVD regulation is among the most confusing areas of FDA regulation.
The IVD rules are scattered throughout the CFRs, and the FDA has issued few guidances to clear things up. Because these products are interrelated, knowing which guidance applies often isn’t clear. Example: Important aspects of GPRs (general purpose reagents) are in the guidance referring to ASRs (Analyte-Specific Reagents). There is no GPR guidance document.
FDAnews has called on one of its most popular presenters, Dan O’Leary of Ombu Enterprises, to straighten things out.
Mr. O’Leary has combed the CFR for every sentence that affects IVDs, and reorganized them by topic for ease of understanding. All participants get their own copy of his fully annotated worksheet. This unique FREE bonus could be worth the registration fee by itself.
The reorganization sheet provides a new framework to understand this complex regulatory area. In just 90 minutes, attendees 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!
Devicemakers, IVD marketers and clinical labs all are vulnerable to running afoul of the FDA in this confusing area. Why risk a Form 483, a warning letter or even worse? Seize this moment to clear up regulatory confusion.
Meet the Presenter:
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…