James R. Ravitz10.21.06
Promoting Medical Devices Prior
to FDA Approval or Clearance
James R. Ravitz,
Arent Fox PLLC
Earlier this year, this column examined the FDA’s regulations and trends with respect to direct-to-consumer advertising. Now we’ll examine the current regulatory policies with respect to promoting unapproved or uncleared devices within the industry—at trade shows, during sales visits to customers and on the Internet, for example.
Device firms, particularly companies that are involved in outsourcing, rely on industry advertising to educate potential purchasers and even investors about their new products. Unlike the more well-defined rules with respect to advertising to patients or the general public, advertising new and unapproved devices within the industry can be a legal gray area.
Given the nature of “me-too” devices, there’s much greater competition in the device industry to promote new Class II devices that are subject to premarket notification procedures, such as a 510(k). The race to develop and commercialize new Class II devices means that companies want to promote them as soon as possible in order to begin taking orders when the 510(k) clears. The rules regarding promotion of an unapproved device tend to vary depending on how the device is regulated. Companies should be aware of these rules to remain both competitive and compliant.
Devices Without
510(k) Clearance
The FDA published a Compliance Policy Guide (CPG), last updated in 1987, concerning the promotion of devices that are the subject of a pending 510(k). This CPG states that “a firm may advertise or display a device that is the subject of a pending 510(k)” application, but that it “may not take orders, or be prepared to take orders, that might result in contracts of sale for the device unless limited to research or investigational use.”
The CPG obviously prohibits the commercial sale, solicitation or taking of orders for a device that is subject to a pending 510(k). However, the CPG is vague in identifying the extent to which a company may “advertise or display” a device. For example, the CPG does not reference whether a company may promote what indications for use are being sought for the device.
Furthermore, the CPG does not clearly define activities that would constitute “preparing to take orders that might result in contracts of sale for the device.” The CPG also does not address whether a company may lawfully promote a product for which no 510(k) notification has been submitted.
At a minimum, companies that are promoting uncleared devices at trade shows or elsewhere should label the device as “INVESTIGATIONAL” and “NOT AVAILABLE FOR COMMERCIAL SALE.” Such labeling is a clear statement that a company does not intend to sell the device.
As a practical matter, if the device has a cleared 510(k) indication and also is subject to a subsequent pending 510(k) for a different indication, then the device should only be promoted for its cleared indications. Promoting devices for the pending indication may be deemed an off-label promotion.
“Almost Approved”
Medical Devices
As opposed to devices subject to premarket notification procedures, the agency has very clear and strict rules regarding the promotion of novel or high-risk Class III devices that are studied under an approved investigational device exemption (IDE) application or are pending approval. The FDA’s regulations prohibit device sponsors and investigators from “promoting or test marketing an investigational device, until after FDA has approved the device for commercial distribution.”
In addition, companies cannot “represent that an investigational device is safe or effective for the purpose for which it is being investigated.” A 1999 FDA guidance document, titled Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects, further clarifies these provisions. It explains that companies intending to publicize the availability of an investigational device to recruit clinical investigators for clinical trials may do the following:
• Announce the device’s availability only in medical and scientific publications or at medical or scientific conferences whose readership or audience is composed primarily of experts
• State clearly that the purpose is only to obtain investigators and not to make the device generally available
• Provide only limited information in the notice, including the name and address of the sponsor, how to apply to be an investigator and how to obtain the device for investigational use
• Use direct mailing for the sole purpose of soliciting qualified experts to conduct investigations
• Include the following statement in the notice: “Caution—Investigational Device, Limited by Federal (or United States) Law to Investigational Use”
• Ensure that they do not include claims that state or even imply that the device is reliable, safe or effective for uses being investigated
The guidance also prohibits the sponsor from comparing the investigational device with other devices and offering volume discounts for its investigational device.
What do these provisions mean for companies hoping to display devices that are subject to an IDE or provide information on devices that are pending approval at trade shows or medical conferences?
Companies can distribute literature to physicians in order to recruit clinical investigators during trade shows or at medical conferences. They cannot, however, sell the investigational devices, take orders or register physicians for training programs. In addition, companies cannot provide any information regarding the safety and effectiveness of the investigational devices.
Finally, they must display the following label on all materials associated with the investigational devices: CAUTION—INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE.
For those medical devices that are almost approved (ie, subject of an approvable letter from the agency), the FDA will review whether the sponsoring firms can promote these devices on a case-by-case basis. In certain circumstances, a company may be permitted to train physicians on the new device. The FDA has been under increasing pressure to have consistent guidance on pre-approval promotional activities. Device firms have taken the position that if a product is not yet on the market, then promotion of a device that is the subject of an approvable letter could not be unlawful, provided that it is not false or misleading.
The industry is encouraging the FDA to take a similar position. However, even if the FDA were to consistently allow the pre-approval promotion of devices, it is likely that such guidance would be reserved only for those devices that have no other approved indications. FDA-approved devices that also are the subject of a pending application for a new indication can be lawfully promoted only for the approved indications. Promoting a previously approved device for any new indication could be deemed as off-label promotion.
510(k) vs. PMA
As a practical matter, device firms may promote devices that are subject to a pending 510(k) or a premarket approval application (PMA) subject to certain restrictions. The rules regarding the promotion of products pending 510(k) are, quite understandably, more relaxed than for devices that require a PMA, given that a 510(k) is based on the notion of substantial equivalence.
In short, a company may advertise or display a device that is subject to pending 510(k) provided that it is not soliciting or accepting orders for the device prior to 510(k) clearance. The FDA takes a harder line with respect to devices that are subject to an IDE or a pending PMA and has many more restrictions on how and when such a device can be promoted. In general, investigational devices should never be promoted as safe and effective.
Companies exhibiting their new devices and products at trade shows, on the Internet or on sales visits should be aware of these basic rules to help ensure that their promotional activities remain compliant.