My understanding is that FDA is committed to beginning to wind down the broad-scale QSIT 1 inspection program for low- and some moderate-risk device makers within 2011, and to re-focusing their inspection force more heavily on inspections for cause and on higher-risk device makers, with some remaining attention to those companies that don't or can't take advantage of the new program.
They accepted voluntary submissions for the test of the Voluntary Audit Submission Program as of six months ago (i.e. submission of two years' ISO 13485 audit reports, with no major nonconformances allowed), and earlier this week announced that the VASP program would have staff prepared to evaluate its initial submissions starting in May or June.
They've already announced that submissions for a permanent program will begin around the end of 2011, so that doesn't leave them much room to decide that the pilot program didn't work.
As secondary evidence of this tectonic shift in FDA resource prioritization, the number of Warning Letters issued to device companies has been dropping for the past two years, and it's now to the point where it's become uncommon for the weekly Warning Letter report to have even one such warning letter for a device maker.
The company for which I work no longer regards readiness for a QSIT 1 inspection as a high priority. If it happens in the remaining months, so be it, but it seems less and less likely. Instead, our focus is on audits by our NB...particularly because a single major nonconformance could negatively affect our FDA relationship for two years.