FDA: Intuitive Surgical Failed to Report Warning
An FDA 483 letter is a notice to a company that FDA inspectors have found a possible violation of federal regulations. The letters are not a final determination by the agency. The company can respond to and contest the findings of such letters.



In a statement issued to CNBC Tuesday, Intuitive said the corrective letter it sent to customers during the period cited by the FDA "was a reiteration of existing FDA-cleared labeling that reminded users on proper use. The observation is that we didn't report that we sent the letter. We documented it as a non-reportable field action to the FDA because it did not change any of the FDA cleared labeling. Over the last several years, we have maintained consistent and ongoing communication with the FDA to include tip cover."