When A Device Maker Must Submit a 510(k)

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Bloomberg BNA Publications published an article on September 13, 2017, indicating that FDA expects to meet the statutory timeline of November 8 for release of the final versions of its two guidances on deciding when to submit a 510(k) for a change to an existing device.  The article entitled, “When Does Changing a Medical Device Trigger FDA Rules?”  includes observations by KKB Partner Suzan Onel on the importance of these guidances.   Click above to read the article.