Device Week, June 22, 2018 FDA Guidance And The MTI Awards

On this week's podcast, we provide a roundup of recent guidance documents issued by US FDA on topics including humanitarian use devices to off-label communications. We also discuss the Medtech Insight Awards. For more information about Medtech Insight and to sign up for a free trial go to bit.ly/2w7LnlR. Learn more about the Medtech Insight Awards and enter to win: https://bit.ly/2HqAuxv Medtech Insight articles addressing topics discussed in this episode: US FDA Tackles HDE 'Probable Benefits' Question In Draft Guidance: https://bit.ly/2l55mec US FDA Encourages Broader Use of Popular IVD Coding Standard, Cautions Off-Label Use: https://bit.ly/2KbvHCu FDA Finalizes Q&A Guidance Docs On Manufacturer Communications, Adding A Few More Details: https://bit.ly/2HKmU8vm Guidewire, Catheter Draft Guidance Docs Address Coating Risks: https://bit.ly/2tBUeJZ Calling A Q-Sub: New Guidance On Seeking Feedback From FDA: https://bit.ly/2KaJPz0