Regulatory Open Forum

Hi everyone,

I am reaching out to gather recommendations for current and comprehensive training programs on FDA regulations or good practices for advertising and promoting medical devices to propose to my team. Over the years, I've completed several courses covering topics such as implied claims, words to avoid, warning letters, dissemination of off-label scientific information, and social media compliance. However, I'm finding it challenging to locate updated materials or courses online through platforms like RAPS, CDRH Learn, etc.

Moreover, I've noticed that many FDA guidances related to this area are still in draft form after several years and have not been finalized. An updated training that addresses the current state of these guidances, explores reasons for their prolonged draft status, and offers best marketing practices for avoiding misbranding or adulteration of devices would be highly beneficial.

Could anyone recommend a training program or resource that is up-to-date and covers these aspects? Your advice would be greatly appreciated.

Thank you in advance for your assistance.

Maria Iacono