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I came across an FDA guidance document – not entirely recent; however, I found it very interesting and worth sharing. It is on voluntary submissions of audit reports done by auditing bodies outside of the FDA.
There are a few take-aways from this article release worth noting. First off – this is a voluntary program, perhaps this is a way for device manufacturers to show the FDA continuous efforts to improve their quality practices. The audits have to be performed using ISO 13485 and performed by one of the GHTF member countries (such as EU, Japan PMDA, TGA, Health Canada, etc.). An interesting thing to note is that after the FDA has reviewed the audit, they can remove that device manufacturer from routine inspection for up to one year. The audit reports can even be submitted to the FDA electronically. And lastly, this is available to both US & foreign establishments. –SJG
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