When Will FDA Start Enforcing QSR (21 CFR Part 820) for CLIA-Certified Labs Making LDTs?

In October 2014, the US FDA flexed its regulatory muscle and released two draft guidance documents that propose to regain regulatory oversight of laboratory-developed tests (LDT) and enforce medical device reporting requirements for LDTs.  In those guidance documents, FDA went into depth to rationalize why it should enforce regulations over LDTs; since then, many CLIA-certified labs have wondered what they should do next, specifically as it relates to their quality management system (QMS). Here’s a quick recap on how we […]

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