Dr. D would like to spend this week’s Devine Guidance (DG) writing about a rare occurrence involving the FDA’s issuance of a warning letter to a media/publishing concern. I would like to thank a dear friend and professional colleague (Bill Knab) for bringing this fairly unique warning letter to the doctor’s attention. Folks, the simple way to determine if a medical device is actually a device, is to follow one simple rule: “If it walks like a duck and quacks like a duck, it is probably a duck.” If that simple rule does nothing for you, try reading Part 807. One of the things that the doctor cherishes about the federal regulations as they pertain to medical devices is that they are generally pretty straightforward and easy to follow, and no, the old doc hasn’t fallen out of his proverbial rocker. However, it appears that compliance continues to be an issue for many device establishments. For device establishments that fail to comply with the Quality System Regulation (QSR) or subsidiary federal codes, a warning letter is in the future for these establishment, and one does not have to be clairvoyant, in possession of a crystal ball, or a reader of Irish tea leaves to see this unfortunate future. The grandiloquence (look-it-up) of the writing styles employed by the FDA in the scripting of warning letters and the verbose-nature of these letters are a direct reflection of the agency’s determination to drive compliance. Fail to comply, get a warning letter. It’s a pretty simple concept, right? Enjoy!
Warning Letter – August 20, 2015
A few months ago, Dr. D covered how the FDA feels about truth in advertising. If an establishment is advertising the virtues of a medical device, the device better be cleared or approved for the intended use in the marketing material. The warning letter award winner discussed in this week’s DG has a cleared product (reference K020800); however, the agency cited in the warning letter that the claims being made on the company’s website differed from what the agency cleared. Unfortunately, when significant changes occur to a cleared (Class II) or approved (Class III) medical device, the FDA expects an establishment to submit a new application (510(k), PMA supplement or PMA). I guess the agency strongly believed that this establishment failed to notify them of the changes. Regardless, I will let the readers decide. Read on!
Warning Letter Excerpt
“The United States Food and Drug Administration (FDA) has learned that your firm is marketing the Quotient ADHD System in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). Under section 201(h) of the Act, 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.”
“The FDA has reviewed your firm’s website at http://www.quotient-adhd.com and determined that the Quotient ADHD System 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 Quotient ADHD System 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 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 Quotient ADHD System (originally named OPTAx System) was cleared under K020800 with the indications for use as a device that provides clinicians with objective measurements of hyperactivity, impulsivity and inattention to aid in the clinical assessment of ADHD. OPTAx results should be interpreted only by qualified professionals. However, your firm’s promotion of the device provides evidence that the device is intended to measure motion and analyze shifts in attention state, monitor response to treatment, help to optimize treatment in weeks instead of months, and help to determine the effectiveness of a new treatment or continued effectiveness of ongoing treatment when clinically indicated. This would constitute a major change or modification to its intended use for which your firm lacks clearance or approval.
Compliance for Dummies
Let the doctor start by stating the obvious: “Device establishments should be able to read and comprehend 21 CFR, Part 807.” Seriously, establishment registration is one of the first steps taken after implementing a quality management system compliant with 21 CFR, Part 820 requirements. Step two for a Class II device is the writing and submission of the 510(k). Once the agency agrees with an establishment’s claim of substantial equivalence, clearance is granted. However, if there is a change in the indication for use, the agency really does want to know about the change. Can you guess what that regulatory pathway is for a change in the indication for use? If your answer is either an abbreviated or special 510(k), sorry, your answer is wrong. In accordance with §807.81, a new 510(k) is required. If you don’t believe the doctor, might I suggest downloading a copy of Part 807 from the FDA’s Website. For establishments that fail to understand this teeny-weeny step, an agency warning letter is probably in the cards.
For this week’s DG, the doctor will leave the readers with one takeaway: If it walks like a duck and quacks like a duck, it is probably a duck. Guess what? The same logic holds true for medical devices. If an establishment is savvy enough to submit an initial 510(k) and obtain clearance, submitting a new 510(k) for a significant change or a change in the indications for use really should be almost as easy as child’s play (for intelligent children). In closing, thank you again for joining Dr. D, and I hope you find value 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. (April 2015). Title 21, Part 807: Establishment registration and device listing for manufacturers and initial importers of devices. Washington, D.C.: U.S. Government Printing Office.
- Code of Federal Regulation. (April 2015). Title 21 Part 820: Quality system regulation. 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. (August 20, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations, NCS Pearson. Accessed September 25, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm463351.htm