After a medical device passes the strict scrutiny of the Food and Drug Administration, it is cleared for marketing in the United States. In general, FDA approval is not withdrawn from a device so long as no material changes are made to its design or intended purpose.
Direct-to-consumer marketing of prescription medication and medical devices is widespread in the United States. However, devices that have not yet achieved regulatory approval cannot be promoted to the general public – only within the industry according to strict rules.
Promoting Devices During the FDA Approval Process
Many medical device firms wish to exploit promotional opportunities available to them in the industry before they have completed FDA clearance for a new innovation. Industry trade shows, in particular, may take place only once a year and are seen by many as “too good to pass up.”
Companies may also be looking ahead to the development of a strategy for on-site demonstrations and even digital marketing. Before launching any of these initiatives, however, it’s important to understand limitations imposed during the regulatory process.
Advertising Class I and Class II Devices
In Commercial Distribution with Regard to Premarket Notification (Section 510(k)) the FDA laid out guidelines related to device promotion during the approval process. These rules allow firms to advertise or display a device subject to a pending 510(k) determination.
However, firms may not take any orders for such devices, nor even be prepared to take them.
FDA rules on the fine points of promoting unapproved devices are vague, and few clarifications have been forthcoming since they were originally specified in the 1980s. For example, no details are given about whether a firm may promote the device’s expected indications for use. Likewise, it does not specify what activities constitute “preparing to take orders.”
Until final approval is secured, devices should be labeled “INVESTIGATIONAL” and “NOT AVAILABLE FOR COMMERCIAL SALE.” If the device holds at least one cleared 501(k) indication and other, pending indications, it should only be promoted for cleared indications.
Failing to maintain this distinction opens a company to accusations of off-label promotion.
Because of the high risk inherent in Class III devices, strict rules limit the scope of their promotion. The promotion or test-marketing of such devices is expressly prohibited, and companies are not permitted to represent that these devices are safe or effective for their investigational purposes.
In 1999, the FDA guidance document Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects laid the groundwork for limited promotional activities intended to recruit study subjects. Among other things, it requires that activity be limited to medical and scientific publications or conferences intended only for experts.
Firms should be sure to recruit only the number of investigators necessary to evaluate the safety and effectiveness of the device. To avoid the appearance of impropriety, mass mailings for the purpose of recruiting clinical investigators should be avoided.
For Medical Device Promotion, the Devil is in the Details
This brief summary should not be relied upon as strategic or legal advice – it’s only a hint of the vast scope of regulatory complexity. While there are marketing steps you can take to lay the foundation of success for your innovation, they are by no means simple.
To avoid self-sabotage, medical device enterprises must navigate promotional issues carefully.
To drive excellent healthcare outcomes and give your device the reputation it deserves, it is crucial to adopt the highest quality standards. Through our expertise in the globally-recognized ISO 13485 quality management approach, Technosoft Innovations makes it easier.
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