LDTs
Top Five Articles on 360Dx Last Week: FDA's New LDT Proposal; Hurdles to POC Routine Testing; More
Last week, readers were most interested in a story about the newest move by the FDA to regulate laboratory-developed tests.
The proposed rule, which is likely to face industry challenges, calls for a four-year phase-in of LDT regulation while also suggesting possible carve-outs.
FDA Releases Proposed Rule for Oversight of Laboratory-Developed Tests
The rule, which would make explicit FDA's authority to regulate LDTs, is certain to face pushback from many in the laboratory and diagnostics industries.
A year after the EU's In Vitro Diagnostic Medical Device Regulation took effect for new products, its implications for manufacturers and diagnostic labs are starting to emerge.
Top Five Articles on 360Dx Last Week: NYS LDT Database; August's FDA 510(k) Clearances; More
Last week, readers were most interested in a story about New York state's LDT database and the insight it may provide into the broader landscape.