Visiting your establishment’s website and reviewing it for compliance issues is not a task that Dr. D routinely sees being performed by quality and regulatory professionals. The promotion of medical devices is considered sacred ground for the sales and marketing teams, while the Information Technology (IT) and web designer folks are doing what is asked of them, creating functional and fabulous websites. However, make no mistake; in this age of technology, with information readily available at the fingertips of our dear friends from FDA, the agency routinely evaluates websites for misbranded and adulterated products, including the promotion of off-label use. It has been the doctor’s experience; the FDA will make a call to an offending establishment and inquire about the content of the website. If the establishment quickly remedies the perceived compliance issue(s), no harm, no foul. However, if an offending establishment fails to address the issues raised by FDA, well (deep subject the doctor knows) things can get interesting quickly for the offending establishment. It is Dr. D’s opinion, many “soi-disant” (look-it-up) quality and regulatory professionals will be scratching their heads when the FDA reaches out for a discussion on website content. There is no doubt in the doctor’s mind that unsubstantiated product claims, posted on an establishment’s website, will result in sleepless nights for Chief Jailable Officers (CJOs) tasked with placating the agency over product promotion issues. Enjoy!
Warning Letter – 05 September 2017
The warning letter that is the topic of this week’s Devine Guidance (DG) is extremely innocuous. In fact, the two observations noted: (a) purchasing controls; and (b) design controls are two of the more frequently cited Form 483 observations. A well-written response and a plan of action that delineates the steps that will be taken to remedy the compliance issues, and the agency would have been happy. However, website issues are another story. During the course of a year, the doctor reviews many websites for my clients for claims and promotional issues that exceed product clearances (Class II devices) or approvals (Class III) devices. Over time, subtle changes made to a website can eventually result in claims and promotional opportunities, putting device establishments into the realm of adulterated product. However, as mentioned in the introduction to this week’s DG, these issues should be remedied quickly, especially after a call from FDA has been received noting concerns and perceived compliance issues.
Warning Letter Excerpt
Introduction – “FDA has reviewed your firm’s current website (www.dynavisioninternational.com/) as noted in the below examples and determined that the Dynavision D2 device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g), for the device as described and marketed. The Dynavision D2 device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution of this device with major changes or modifications to the intended use without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR § 807.81(a)(3)(ii).”
“Specifically, the previous model, Dynavision 2000, was cleared under K911938 with the indication for use stated as “measurement of reaction time.” However, your firm’s promotion of the device provides evidence that the device is intended for a number of indications not cleared under this 510(k), which would constitute a major change or modification to its intended use, for which your firm lacks clearance or approval. Any therapeutic or rehabilitation claims and/or any diagnostic claims beyond the measurement of reaction time constitute a new intended use and require submission of a 510(k) prior to marketing of the device for such claims. This includes any rehabilitation claims related to stroke.”
21 CFR, Part 807 – Establishment Registration and Device Listing for Manufacturers and Initial Importers of Medical Devices
21 CFR, Part 807.81 – When a Pre-Market Notification Submission is Required
(3) The device is one that the person currently has in commercial distribution or is reintroducing into commercial distribution, but that is about to be significantly changed or modified in design, components, method of manufacture, or intended use. The following constitute significant changes or modifications that require a premarket notification:
(i) A change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process.
(ii) A major change or modification in the intended use of the device.
Compliance for Dummies
The doctor often hears from device manufacturers that advertising their products is a gray area and additional dispensation is typically granted from regulators. This statement could not be further from the truth. In fact, often it is an establishment’s competitors that “rat-them-out” to FDA. My dear readers, you would be shocked if you actually knew how many times this squealing to the FDA actually occurs. However, device establishments do not have to fall prey to this childish behavior. How is that possible, Dr. D? The answer is eloquent in its simplicity, just comply baby!
Seriously, there are basic and common sense steps device establishments can pursue that will keep them in the good graces of our friends from FDA.
- One – promote only the indications for use that have been reviewed and cleared (or approved) by FDA;
- Two – place the material being posted on the website under document control (treat it like product labeling);
- Three – ensure regulatory affairs reviews and approves all content. If your establishment does not have a regulatory affairs function, find a competent consultant to review (one who is familiar with your products);
- Four – include the website in your annual audit program. The content should be audited to ensure changes are not being made or there is a mild migration into the realm of off-label use; and
- Five – if the FDA calls and takes exception to the website, resolve the issue(s) quickly. It is ok to disagree with the FDA. However, if you are going to discuss content be prepared to defend your establishment’s position. As Deming would say; “In God we trust, all others bring data.”
For this week’s guidance, the doctor will leave the readers with two takeaways. One – if the FDA calls and expresses concerns over your establishment’s website, address those concerns quickly. Two – it is imperative that the product information placed on an establishment’s website is accurate. Promoting off-label use or an expanded indication for use that has not been reviewed and cleared (or approved) by FDA is going to be problematic. Can you say adulterated product? In closing, thank you again for joining Dr. D; and the doctor hopes you found value (and some humor) in the guidance provided. Until the next installment of DG – cheers from Dr. D. and best wishes for continued professional success.
- Code of Federal Regulation. (2017, April). Title 21 Part 807: Establishment registration and
device listing for manufacturers and initial importers of medical devices. Washington, D.C.: U.S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
- Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
- FDA’s enforcement page. (2017, September). FDA.gov Website. Retrieved September 23, 2017,