FDA will publish shortly a guidance document on how the agency will use ISO 13485 audit reports voluntarily submitted by device manufacturers. The idea is that these manufacturers can be classified as a “low priority inspection” need because they will have shown the FDA that they have already been audited. This way FDA can focus on manufacturers which do not have a ISO audited system.

Original nrews from the website site FDANews.com - FDA Plans to Release ISO Audit Guidance Shortly.

I was warned at the Elsmar Cove Forum - thanks Dustyn!