Folks, for this week’s guidance, Dr. D will dive into the perils associated with making outrageous product claims or claims outside of the scope of cleared and/or approved medical devices. The FDA has really stepped up enforcement activity when it comes to truth in advertising issues associated with claims made by device establishments either in literature or on websites. The target of the FDA’s wrath associated with this week’s warning letter managed to turn a treadmill and a stationary exercise bike into something right out of Star Trek, with claims that clearly read like clearance is required in accordance with 21 CFR, Part 807 requirements. The agency spent an entire month in Hood River, OR (June 1 through July 2, 2015) for the purpose of inspecting this offending establishment. The doctor’s initial conclusion was that the inspection lasted just a few days, with the balance of the inspection focused on trying to find Sasquatch (a.k.a., Mr. Big Foot). Heck, once found, Big Foot could have jumped onto one of the treadmills and/or exercise bikes (great photo op missed). Regardless, for the effete (look-it-up) CJOs out there that have to defend their establishment’s marketing transgressions, the FDA is watching. Enjoy!

Warning Letter – December 22, 2015

CJO’s, please take the following Dr. D message to heart. When a device establishment, in this case an importer and distributor of exercise equipment, makes outlandish medical claims for a treadmill, stationary bike or similar apparatus, it is just a matter of time before FDA magically appears in the lobby of the offending establishment for a cup of coffee and an inspection.  When claims such as the following (extracted from the warning letter) are made for exercise equipment, Houston we have a problem:

• “Stimulating HGH, human growth hormone, improve performance of slow twitch muscle fibers;”
• “Drainage and Clearing of Lymphatic Fluids…Rehabilitation of Injuries…Collagen Production…Secretion of Hormones such as HGH-Human Growth Hormone, IGF-1 & Testosterone…Creation of…Hormone Serotonin & Norepinephrine…Bone Density;”
• “Improves blood, oxygen and lymph circulation, which can also contribute to the prevention of metabolic, musculoskeletal [sic], and degenerative disorders;”
• Rehabilitation of women with Knee osteoarthritis;”
• “Helps to lower Cortisol, a stress hormone…resulting in a natural, drug-free pain management exercise system without side effects;” and/or
• “Anerobic [sic] pathogens, parasites or a disease-condition cannot survive a highly oxygenated environment, including the blood stream of the Human body.”

If an individual is weight-challenged due to a lack of vertical growth, or one is seeking to get into better physical shape (kind of like Dr. D), then a treadmill or bike is a viable option. Simply stated, no medical claims should be made, other than the potential for some weight loss with regular use. In fact, warnings pertaining to the potential for myocardial infarction (heart attack if you must ask) may be more appropriate.

Warning Letter Excerpt

“Under Title 21 Code of Federal Regulations (CFR) Part 890.5380, although powered exercise equipment intended for medical purposes are Class I devices exempt from the premarket notification procedures under Subpart E of 21 CFR part 807, they are subject to the limitations in 21 CFR 890.9. These limitations provide, in relevant part, that “manufacturers . . . must still submit a premarket notification to FDA . . . when . . . [t]he device is intended for a use different from the intended use of a legally marketed device in that generic type of device . . . .” 21 CFR 890.9.”

“Generic devices of this type (e.g., a powered treadmill, a powered bicycle, and powered parallel bars) are intended for limited medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Our inspection revealed, however, that your firm markets the Professional VC-12, Pulsation VM-10 and Personal VH-11 whole body vibration devices with therapeutic and/or structure/function claims that exceed the limitations of the intended uses for powered exercise equipment.”

21 CFR, Part 890.5380 – Powered Exercise Equipment

“(a) Identification. Powered exercise equipment consist of powered devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Examples include a powered treadmill, a powered bicycle, and powered parallel bars.”

“(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 890.9.”

Compliance for Dummies

In looking at 21 CFR Part 890.5380, the doctor is struggling to find where  “Drainage and Clearing of Lymphatic Fluids” is stated in the identification—oops, not there. What about “improves blood, oxygen and lymph circulation?” Guess what, it is not there either. The doctor thinks that this device is clearly misclassified, and the CJO had some significant explaining to do.

For this week’s guidance, the only thing Dr. D can really emphasize is the use of a little common sense and maybe a muzzle for an aggressive sales and marketing group. Device establishments cannot make claims outside of the intended use of their devices. For example, if the device in question has been listed with the FDA as a Class I device (e.g., treadmill), then the intended use better align with the use (identification) delineated by the FDA within 21 CFR Part 862 through Part 892 (with the exception of reserve devices). If the FDA believes that a device establishment has exceeded the intended use of a device with unsupported medical claims (therapeutic or diagnostic), then rest-assured, a warning letter will be in the offending establishment’s future. One does not need a set of Tarot cards to see into this future and know that bad things are going to happen. For example, if the recipient of the warning letter referenced in this week’s guidance simply stated, “it can assist the user in the fight against obesity,” just maybe FDA may not have paid them a visit. In fact, your tax dollars could have been spent on finding big foot instead (just kidding). However, if a device establishment seriously wants to expand the indication for use, then 21 CFR Part 807 is going to become the CJO’s best friend, if the appropriate regulatory and statutory steps are completed.

Takeaways

For this week’s guidance, Dr. D will leave the readers with just one takeaway. Please do not make outlandish and unsupported claims for a medical device. If a device has been cleared for draining urine, then the Instructions for Use (IFU), product labeling, and marketing material should clearly state: Used for draining urine. Conversely, if the medical device has pedals, a wheel and a stand, it is probably a stationary bike (Class I) for exercise. It should be advertised as such (e.g., can help fat people like Dr. D lose some weight and get into better shape). 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.

References

1. Code of Federal Regulation. (2015, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
2. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system   regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
3. Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
4. FDA. (December 22, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Sonic Life.com, LLC. Accessed January 23, 2016.Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm478988.htm