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.
