Business leaders of all sectors are well aware of the rapidly and continually increasing effectiveness of online marketing, but few are subject to the types of regulations, factors and concerns that impact medical device retailers.
The FDA regulates both the labeling and advertising of restricted devices, but for non restricted devices it regulates labeling only. But since the FDA’s stance on what constitutes online advertising vs. labeling is somewhat ambiguous, this can be tricky landscape to navigate.
In order to avoid blurred lines and unwanted FDA scrutiny, we recommend an err-on-the-side-of-caution approach and have compiled some helpful guidelines:
- Avoid misleading representations or omissions when promoting your product, including making subjective statements or misrepresentations of competitor products.
- Never deviate from approved uses when describing your product.
- Understand that you may need to use different language in cases when your target audience is comprised of laypeople rather than medical professionals.
- Make your language digestible for laypeople without deviating from the facts regarding your product’s indications, claims, related studies, etc.
- Talk about premarket approval within relevant campaigns, but only announce a 510(K) clearance one time, in the form of a press release.
- Only do product comparisons that are based on “head-to-head” studies, are statistically significant, and reflect primary endpoints.
- Make sure the graphics and images used when promoting your products don’t suggest or imply claims or information that are false.
- Never list your product’s risk/benefit information on social media platforms with character-space limitations but, when applicable, provide a link to a webpage or PDF (that is not an advertisement) where this information can be discussed in full detail.
- Avoid disseminating or linking to any information provided by independent third-parties.
At Solutions 8, we have a full appreciation for FDA guidelines, so our medical device campaigns never run afoul of regulations while still remaining as powerful, compelling, and successful as those we do for any industry.
If you’re looking for an outstanding digital marketing team that will cover all your bases, from strategy to original content creation, social media management to metric tracking, and will never fail to consider the importance of protecting your company from liability or FDA scrutiny, contact us today for a free consultation.