The FDA expects device manufacturers to promote both benefit and risk information in every social media post. This includes the 140 character limit of Twitter! They expand this requirement to sponsor links and social media ads. In the eyes of the FDA, if you cannot follow the recommendations, then manufacturers should “reconsider using the platform.” The reality is that only low risk products will be able to follow the guidance. In addition to the character limitations, the FDA is recommending including a link to a website subpage that is dedicated exclusively to risk information.
All messages on social media should include the following:
- Non-misleading information
- Product name; brand name as well as generic name
- Indications and use restrictions
- Link to website risk subpage
- Non-promotional in content and tone
With the FDA trying to appease the general manufacturing public, they have imposed regulations that are too strict. This is going to rule out any social media marketing for medium and high risk devices. Social media marketing will be ruled by low risk devices, and they are going to thrive without the competition.
The full guidance can be reviewed here :