DA issues new draft Guidance Document on Assay Migration Studies for IVDs

The FDA issued a draft Guidance Document on IVD Assay Migration for comments and suggestions. The comment period closes April 6, 2009. The guidance covers “Class III or certain licensed in vitro diagnostic devices in cases when a previously approved or licensed assay is migrating (i.e., transitioning) to another system for which the assay has not been previously approved or licensed.” However, it may also apply to 510(k) devices where the Replacement Reagent and Instrument Family Policy does not apply and to devices where the transition specific concerns. You can view the draft guidance at http://www.fda.gov/cdrh/oivd/guidance/1660.pdf. You can see the submitted comments at http://www.regulations.gov/search/index.jsp after you enter the document number FDA–2008–D–0642.