FDA Compliance in Marketing – A Company’s Digital Experience Has the Most Violations Followed Closely by Trade Shows.

Just finished an AGG webinar that reinforced a lot of things to remember when you are planning your next trade show or digital experience. Here are a few key lessons tempered with some of the down-in-the-trenches experience at Ubiquity. As enforcement is on the rise, we want to help you get it right at the trade show and in your digital communication.

Where are the violations?
30% of DDMAC Warning Letters in 2010 cited internet violations. Trade shows were the second most common area for violations. New FDA Guidelines for internet are due out in Q1 or Q2 2011.

What can you do to prevent violations on the internet?

1. Develop a review process for all communications and use it relentlessly with a digital signature.
2. You will need to monitor what others are saying about your product. Be a good listener on social media sites. If a customer or other user is making false or misleading claims about your product, create a process to notify them and document the notification.
3. Regarding database and SEO, you may enter your product in databases or search engines for similar products or supplemental uses; you may not make suggestions or representations of unapproved uses in your communications.
4. Update promotional review policies to consider risk communication on the Internet and sponsored links.
5. Choose a marketing firm with experience and education in Medical Device promotional compliance.

What can you do to prevent violations at trade shows?

1. Always review materials for each new venue and audience.
2. Train all of your trade show staff completely prior to each and every show.
3. No hand-made materials – meaning sales staff shouldn’t show up with hand- made power point presentations!
4. Insure that you have provided all reporters and analysts with the correct information and document this. If they make a false claim later, you are protected.
5. FDA allows the display of a medical device with a pending 510(K) premarket notification under review with the qualifier that the product is not cleared for marketing. You may not take orders.
6. Separate commercial and investigational products within the booth to make clear the regulatory status of each product. A good booth design should allow for change and evolve with each new venue and audience.

Here is a useful sites for FDA Promotion regulations.