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Monthly Archives: October 2017

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FDA Finalizes 510(k) Guidances on When to Submit a New 510(k)

Category : FDA, Medical Device testing, Regulatory

On October 25, 2017, the FDA released two final guidance documents: “Deciding When to Submit a 510(k) for a Change to an Existing Device,” which applies to medical device changes broadly, and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device,” which focuses on software-specific changes and complements the broader guidance document.  These guidance documents

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