Device Week, June 22, 2018 – FDA Guidance And The MTI Awards
Executive Summary
On this week's podcast, we provide a roundup of recent guidance documents issued by US FDA on topics ranging from humanitarian use devices to off-label communications. We also discuss the Medtech Insight Awards.
Listen to the podcast via the player below:
MTI Awards
Click here to learn more about the Medtech Insight Awards and enter nominations.
Medtech Insight articles addressing topics discussed in this episode:
- US FDA Tackles HDE 'Probable Benefits' Question In Draft Guidance
- US FDA Encourages Broader Use of Popular IVD Coding Standard, Cautions Off-Label Use
- FDA Finalizes Q&A Guidance Docs On Manufacturer Communications, Adding A Few More Details
- Guidewire, Catheter Draft Guidance Docs Address Coating Risks
- Calling A Q-Sub: New Guidance On Seeking Feedback From FDA