HCV draft guidance
This article was originally published in The Gray Sheet
"Premarket Approval for In Vitro Diagnostics Devices Pertaining to Hepatitis C Viruses (HCV)" is released April 27. The draft replaces an earlier version released in October 1999. Although the changes are relatively minor, the agency explains that it received so many comments during the initial comment period for the first draft that it wanted to offer another 90-day comment period
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