Intended Use and Indications for Use
Device Tips, FDA, Indications for Use, Intended Use, Judy Martin, Warning Letters
Introduction: This device tip was written by new Associate Judy Martin. Judy has over 25 years in the medical device and IVD industries. She is experienced in 510(k) submissions, design control, process improvement, recall management, product labeling development and FDA remediation activities. Judy has particular expertise in device promotion and advertising, including process development and claims substantiation, and extensive expertise in website promotion and regulatory aspects of social media promotion. Judy has a BA in Biology, a BS in Medical Technology, and an MBA.
In the first few months of 2014, there were numerous Warning Letters issued by the FDA to device manufacturers for promoting products outside their cleared intended use or indication for use. This is a serious violation and could result in misbranding and/or adulteration, which prevents the device from being marketed in the U.S. Depending on the severity of the circumstances, there could also be product seizure, injunctions against the company and civil money penalties. Do you know the parameters for promoting your devices?
It is important to identify the claims you want to make for your product in the development phase of product design. In other words, what do you want to say about your new device? What does it do, who will use it, when and where are the appropriate situations that it will be beneficial? The answer to these questions will determine the device’s intended use and the indications for use to be included in your regulatory submission.
Here are a couple of tips:
- It is important to clearly identify all the device’s intended uses/indications for use in your regulatory submission.
- When developing any promotional materials, including electronic media or educational programs, stick to the claims in your device’s regulatory submission.
The first could be accomplished by including examples of draft advertisements you plan to use for product promotion in your submission to the FDA, with all explicit and implied claims included. This allows FDA to evaluate the promotional strategy during the submission process. Once the product is launched, it should be standard practice to evaluate product promotions to ensure they remain consistent with claims in the submission.
The second is a matter of discipline throughout the lifecycle of the product.
More Info On Intended Use
Intended use is defined in 21CFR 801.4 as “the objective intent of the persons legally responsible for the labeling of devices.” It is further explained this way: “The intent is determined by such persons’ expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives.” Based on this definition, intended use is determined by all circumstances of distribution, including a device’s labeling and advertising.
Indications for Use is defined in 21CFR 814.20(b)(3)(i) as “a general description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended.”
Examples of intended use could be “to measure blood warfarin levels” or “a diagnostic device to produce images of the brain.” Examples of indications for use of these devices could be “to measure warfarin levels in capillary blood by an adult patient in the home” and “a diagnostic device to produce images of the brain to assess electrical activity during sleep,” respectively. If the warfarin device cleared for the above intended use/indication for use was promoted to measure something other than warfarin, with arterial or venous blood or in a different patient population, these would constitute new intended uses or indications for use.
Some of the device Warning Letters from this year related to expanded intended use/indications for use include:
- Bandages that were cleared for temporary control of bleeding were promoted as a product to shorten bleeding time and reduce the risk of infection. FDA perceives this as a new intended use of the product. Even though some of the data had been included in the submission, the new claims were not included in the formal intended use/indications for use statement in the 510(k) and therefore FDA said a new submission is required.
- A laser device cleared for temporary increase in clear nails was promoted to treat nail infection. FDA perceives treatment as a new intended use of the device.
- An external penile rigidity device cleared for penile erection in impotent men was promoted for penile enlargement. This was also viewed by FDA as a new intended use.
- A dental light to assist in visualization of oral abnormalities was promoted for early detection of oral abnormalities; again, a new intended use for detection, as opposed to visualization.
- A thermocoagulation device to treat lower limb spider veins was promoted for treatment for facial red veins and rosacea. The Warning Letter says this is a new intended use. I might argue it is a new indication for use, but the outcome is the same – the device is adulterated and misbranded and a new regulatory submission is required.
- A high frequency generator cleared for use with electrosurgical units in low power microsurgical applications to remove, destroy and coagulate tissue was promoted to treat glaucoma. This is an example of attempting to use a clearance for a general intended use and transfer it to a specific use. From FDA’s perspective, this is not acceptable and requires a new submission.
It is interesting to note that some of these Warning Letters came from facility inspections, but some came from FDA’s review of websites and conference materials. When developing any promotional materials, including electronic media or educational programs, you should remember to stick to the claims for your device that have been included in your regulatory submission.