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FDA Oversight of Laboratory Developed Tests

Industry stakeholders are seeking further clarification from the Food and Drug Administration (FDA) on exactly how the agency expects to measure the risk that a laboratory-developed test poses to consumers. In a public workshop held January 8-9, 2014 in Bethesda, Maryland. More than 80 stakeholders, comprised of IVD manufacturers, laboratories and trade groups, testified during the two-day workshop, with many opposing efforts by the FDA to regulate LDTs.
Posted: December 26th, 2014 | Permalink

LDT Regulatory Framework & Notification Guidance Explained

The FDA is proposing the following draft guidance documents as the first step in addressing concerns related to Laboratory Development Tests (LDTs). Start preparing for these upcoming changes now by having an understanding of how these regulations will impact your laboratory. Premarket quality assessment and post-market reporting will be paramount for laboratories moving forward.
Posted: August 28th, 2014 | Permalink

Future Changes for Laboratory Developed Tests (LDTs) Expected

The Food and Drug Administration (FDA) will be delivering two draft guidance documents related to oversight of LDTs. Contemporary trends in healthcare look to LTDs as a means for carrying out personalized treatment plans to better treat high-risk diseases.
Posted: August 22nd, 2014 | Permalink

Preparing for Clinical Laboratory Reimbursement Cuts from H.R. 4302

Find out what H.R. 4302 means for your laboratory and clinical lab payments.
Posted: June 26th, 2014 | Permalink

Addressing Patient Communication in the Laboratory

In many cases policy can provoke a drastic need for operational change by several other stakeholders in health, like clinical laboratories. They way that a laboratory communicates with patients, providers and insurance companies has certainly changed. Policy changes can be a challenge as well as an opportunity for a more collaborative approach to public health.
Posted: June 16th, 2014 | Permalink