Treading murky waters
We know how complex the regulations can be – the most common pitfalls companies face are associated with social media marketing and digital influencers. One misinterpretation of a word can cause you large setbacks with respect to time and money.
Insight and practical guidance can help you to bolster your compliance policies and procedures and keep your marketing efforts on track.
There are four current draft guidances that address promotion and advertising of both prescription drugs and restricted medical devices. However, the FDA has not finalized or drafted guidance documents specific to non-restricted medical devices, therefore, it can feel like you are treading murky waters while trying to interpret these guidances.
- Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices
- Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics*
- Internet/Social Media Platforms with Character Space Limitations –Presenting Risk Information for Prescription Drugs and Medical Devices
- Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices
- Internet/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices –Use of Links to Third-Party Sites
Well, what if my device is a non-restricted device?
We hear this a lot. And the answer is that it is not so black and white as it depends on your unique device. The FDA may be incredibly clear on what is applicable to restricted devices or prescription drugs yet entirely unclear about what is required for your non-restricted device.
It takes experience with working with FDA agents and lawyers to determine what regulatory laws apply to your device. Understanding what does apply to restricted devices can give you a good indication of what types of “red flags” the FDA and other regulatory agencies would be looking for. However, there will be a point in your journey where you have to make some risk based decisions and this is where we advise you to seek assistance from experienced professionals.
Navigating the FDA never goes away.
At Cosm, we believe that in order to succeed and set your company up for long term success, it is best to deeply understand the ins and outs of the regulatory guidelines that apply to your unique device.
We guide you through the process and ensure your decisions are appropriate for your device with the least amount of risk possible. However, we encourage you to learn the skills yourself, that way you feel more confident in your decision making and risk management going forward.
Checkout our more in-depth article on promotional and advertisement regulations here.
Further Advertising & Promotional Guidances, applicable to medical devices:
- Presenting Risk Information in Prescription Drug and Medical Device Promotion
- Distributing Scientific and Medical Publications on Unapproved New Uses —Recommended Practices
- Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements
- For the full list of advertising & promotion guidances, visit the FDA website.