I can not find the exact FDA regulation to see if they explicitly spell out price.But remember price discussions are a form of promotion.I did find a device statute which comes close to what i was thinking .Remember selling on price is a promotional strategy in nature.Its so damn hard to find anything in searching the FDA
Prelaunch promotions. Devices that are pending clearance or approval cannot be promoted. This applies to all product literature, labeling, communications, and advertising. Likewise, the indications for use may not be stated or implied, and no claims of safety or efficacy may be made. This is because prior to clearance or approval, the manufacturer cannot ascertain which claims will be accepted by FDA. Therefore, the device cannot be considered safe or effective. The investigational device exemption (IDE) regulations also prohibit promotion of devices that have not yet been cleared or approved for marketing by FDA. This includes promotion or test marketing of investigational devices, or representations made that a device is safe or effective for the purposes for which it is being investigated. It should be noted that companies can communicate prelaunch information about unapproved products by using press releases on product development activities and having scientists provide presentations at meetings, within the context of a scientific and educational activity.
AI
