Don't Finalize LDT Guidance, House Appropriators Tell FDA
This article was originally published in The Gray Sheet
FDA should "suspend further efforts to finalize the laboratory-developed test guidance" and instead work with Congress on a new regulatory pathway for LDTs, House appropriators told the agency in an FY 2017 spending bill, which also adds $10 million to fight the Zika virus.
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In Case You Missed It: Top 10 Gray Sheet Stories In April
A podcast interview and a feature story delving into the recent international ISO 13485 quality systems standard revision were the most popular items at TheGraySheet.com last month. Our continuing coverage of off-label communication questions in the courts and the laboratory-developed test debate attracted attention, along with a piece on biocompatibility testing tips from FDA officials. Also: popular Gray Sheet podcasts from April.