The firm says an FDA warning letter it received cites violations based on “recent updates” to FDA’s Medical Device Reporting program made in a draft guidance last year. But FDA emphasizes that it does not take enforcement actions based on how a company implements a guidance document, draft or final.
DexCom Inc. says FDA investigators concluded last November that the firm’s adverse event reporting system was not compliant with “recent updates” related to the Medical Device Reporting regulation, resulting in a warning letter the firm announced on March 25. But FDA says that is a misstatement of the letter’s content, and that the agency does not take enforcement action based on how a company implements a guidance document, draft or final.
The warning letter, which was posted online
Notified bodies are calling for their key role, as the technical, regulatory and clinical ‘extended arm’ of regulatory authorities, to remain central to the EU medtech conformity assessment process.
The US FDA has announced its user fees for fiscal 2026, which are based on a figure of $455,000 for a PMA.
NHS England's national chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.
