FDA Requirements/Restrictions - Medical Device and Drug Companies.
While the FDA prohibits commercialization of investigational devices before they are on the market, there are some allowable methods of corporate communication from the companies developing these devices. Below, I will outline the acceptable and unacceptable practices for medical device or drug companies wishing to communicate their pre-market product to others. The main things to avoid when communicating about an investigational device are the appearance of attempting to make money and the appearance that the device has already been approved by the FDA.
The FDA currently uses "Preparing Notices of Availability of
Investigational Medical Devices and for Recruiting Study Subjects" as its guide on promotion of pre-market investigational devices. This document was issued in 1999 but is still the operating guidelines today. The basic restrictions regarding communication of an investigational device to attract investigators are:
1. Announcement of the device should only be made in medical or scientific publications or conferences whose audiences are mostly experts with experience in investigating these devices.
2. Obtaining investigators should be the clear goal of communication, not making the device available. Obtaining an excessive amount of investigators is considered promotional.
3. The information presented should only include the proposed use of the device, the name and address of the sponsor, the roles and responsibilities of an investigator, and how to become an investigator and obtain the product for investigational use.
4. Mailings should be directed at qualified experts; undirected mailing is considered promotional.
5. The following disclaimer should be included in a font at least as large as the largest text on the notice: "Caution – INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE."
6. Communication cannot state or imply that the device is "reliable, durable, dependable, safe, or effective."
7. Communication cannot compare the device to any other device.
8. Communication cannot offer volume discounts of the device as this is considered promotional.
With regard to participant recruitment for an investigational device, the FDA restrictions are:
1. IRB approval must be obtained for the information presented in any communication.
2. Communication cannot state or imply that the device is safe or effective or equivalent or superior to other products.
3. Devices cannot be described as "new treatments" without stating that the device is investigational.
4. Communication cannot advertise "free medical treatment" if participants are not charged for participating. If participants are paid, the communication may mention payment without emphasis or the amount paid.
Acceptable communication of investigational devices
Based on the FDA restrictions, some examples of acceptable communication are:
Signs next to the device marketing that say "Caution: Investigational Device. Limited by Federal (or United States) Law to Investigational Use."
Communication that does not interpret study findings and labels all incomplete data as "preliminary."
Unacceptable communication of investigational devices
In addition to the restrictions clearly stated in the FDA guidelines, some other forms of communication that are restricted are:
Claims that the product is a "breakthrough" product in drugs/medical devices.
Offers to take orders for devices or give them away to investigators.
Promotion of an approved device for unapproved or investigational uses. Unapproved or investigational uses of an approved device are against FDA 510(k) clearance.
Tips to ensure investigational device communication is acceptable
Julie Tibbets, one of the best lawyers in the US for FDA law, recommends a few strategies to ensure drug and medical device companies operate within FDA limits for device communication:
"Ensure scientific or medical personnel, rather than sales or marketing personnel, lead company communications regarding premarket devices."
"Ensure premarket communications identify pipeline products as investigational and present the steps remaining to clearance or approval."
"Ensure the look and feel and overall impression of premarket communications is not promotional."
As far as restrictions that are applicable to website communication of an investigational device, we used FDA guidelines and expert opinions to find a few parameters for companies to consider. Do not make claims about a product's effectiveness, safety, superiority, or reliability, and do not say it is a "new treatment," "free medical treatment," or "breakthrough" treatment for participant recruitment. Always make a large disclaimer that the device is investigational and not for sale in the US. Do not compare the investigational device to any other device. List the proposed uses of the device and information for potential investigators. Make sure to obtain IRB approval for the content displayed on the website.