Join Nerac Regulatory analysts Roz Sweeney, Ph.D. and Donna Mitchell-Magaldi for this powerful discussion designed to give you the insights and information you need on the new EU/FDA regulatory proposals/guidances and how they will be implemented by the agencies!!
It is imperative that IVD manufacturers prepare for upcoming/new regulatory changes in both the EU and US. CLIA labs in the US need to be ready for expected regulatory changes, with enforcement expected to begin around Q4, 2015.
In this portion of the webinar, we will discuss the most up to date (straight from RAPS Conference) information concerning the new EU classification system and what this means in terms of the amount of regulatory oversight for each, including:
- Which IVDs will fall into which category?
- When do auditors plan on implementing the system?
- How much time will IVD companies have to comply?
- What are the compliance requirements, such as product sampling, new clinical data requirements, unannounced audits and more!
This portion of the webinar will cover the new draft guidance on laboratory developed tests (LDTs) for CLIA labs, including:
- Timeframe for implementation by the agency
- Which assays will likely be excluded from the law
- Which assays will be considered high, medium, and low risk
- New requirements for LDTs
Finally, we will discuss FDA guidance on assay migration studies and RUO/IUO assays.
Did you miss the webcast? You can listen and watch it here!
- Webcast: In Vitro Diagnostics - Upcoming Regulatory Developments in the U.S. and European Union: Are You Ready for the Transition?61Did you miss our recent webcast "In Vitro Diagnostics - Upcoming Regulatory Developments in the US and EU: Are You Ready for the Transition?" You can listen and watch it here.
- 57By Roz Sweeney, Ph.D., Nerac Analyst Originally Published: November 17th, 2014 Introduction The FDA recently issued updated draft guidance for proposed regulatory changes affecting laboratory developed tests (LDTs). Laboratory developed tests (or LDTs) are traditionally IVDs developed and used by CLIA labs for treating or testing patients within that lab’s associated healthcare facility. They have…
- 40Originally published February, 2011 Introduction Bringing a new functional food product to market is a potentially complex process with many decision points driven by the US Food and Drug Administration’s (FDA) regulatory mandate. There is no single definition for functional foods, also known as nutraceuticals. They may encompass a range of products and uses, including…