I hate to be a killjoy and sound like I'm pitching our product - but having gone to your site (painspot.com) and played with it, I think you are in potentially a high risk status right now. while your caveat of:
Based on your answers, you are at risk of having one of the following conditions listed below.
Please remember there may be other conditions causing your pain that are not listed below.
Please print or save answers and discuss them with your licensed health care provider.
suggests the person consult a licensed health care provider, the prior step and the URL speak of a "diagnoses" - and that arguably makes your web site a Medical Device requiring at least 510k Clearance.
This is a tough area, and can be very expensive to get clarity on, since medical device consultants and legal advisers charge upwards of $300/hr with 8hr minimums. ClearRoadmap's Pathway tool (https://ClearRoadmap.com ) seeks to help you through this forest of regulations. If you would like to try it free for a week to see if it is right for you, please feel free to email me at firstname.lastname@example.org
We launched our product with the goal of helping innovators like you- and I think some fairly simple changes in your text and claims could get you back in the clear. But I'm not the expert here. The content on the Pathways tool was built by a former Entrepreneur in Residence at the FDA CDRH and it provides all the guidances and best practices in one place.
This is crucial because there are quite a few gotchas that aren't clear if you don't read the documents or follow the FDA analytics process in the correct order.
Interesting website Doug. We are in a similar spot and I am happy to share my thoughts. There is certainly value in pharma ads and rightfully so. However, we are also discovering that there is value in pharma education as well. Being driven as a patient site, there are certainly more than one avenues open for you. I realize this question was posted a while back, but I am happy to discuss further should you be interested.
Thanks and good luck.