Seminar - Online
The webinar clarifies the regulatory concern that FDA has and whether subjecting Laboratory Developed Tests (LDTs) to FDA's device Quality System Regulation can make a measurable difference in the safety and effectiveness (reliability) of special IVDs. The arguments on both sides of the issue will be identified and how regulation may adversely impact the quality of health care we have today. The presumption by FDA is that regulation will improve these special IVDs and, thereby, improve the quality of health care.
Organization: Compliance Trainings (https://compliancetrainings.com)
For more information, please visit: https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1552