The doctor received an email after last week’s guidance from an irate reader (a.k.a. an acquaintance of Dr. D’s). Evidently, this reader (thank you for reading Devine Guidance by the way) was upset about the way Dr. D continues to throw device establishments under the proverbial bus, a bus driven by FDA investigators (note: the bus has Maryland tags). In fact, the phrase used in the email was “mean spirited.” Now Dr. D will be the first to admit that his approach to writing can be a little irreverent and upsetting to some Chief Jailable Officers (CJOs). However, the doctor is trying to educate quality and regulatory professionals about the perils associated with alienating our friends from the FDA. Simply put, one cannot sugarcoat compliance issues, when such transgressions occur. By now, the readers of Dr. D’s weekly rants understand that the doctor strongly believes in his mantra: “There is no such thing as minimum or maximum compliance, there is only compliance!” That being said, the Dr. D has occasionally thrown FDA under the bus, when the doctor believes they have missed an enforcement opportunity, or for no apparent reason has decided to throw a device establishment under the FDA’s big bus.

Remember, enforcement—similar to compliance—is not always an exact science. Sometimes personalities clash, and bad things happen to good device establishments as a result. Regardless, as quality and regulatory professionals, it is our responsibility to ensure that medical devices are safe and effective in their intended use. The way establishments reach that goal in the United States is through compliance with federal regulations. If Dr. D comes across as “mean spirited” when preaching from his pulpit, so be it. It is not like the doctor is an algid (look-it-up) and heartless individual (well, maybe just a little). The doctor really does care about compliance and keeping establishments in the good graces of the agency. Dr. D’s salient goal is to ensure CJOs are well-prepared when they sit across from that friendly FDA investigator, when the investigator magically appears in the lobby for a cup of coffee and an inspection. However, the doctor also has to make reading this column entertaining, too. After all, quality and regulatory compliance can be a really dull topic to read about (try writing about it). Enjoy!     

U.S. Department of Justice Press Release – October 5, 2015

“SAN DIEGO – United States Attorney Laura E. Duffy announced today that David Arthur, the manufacturer of an unapproved medical device, was sentenced by United States District Judge Roger T. Benitez to serve 18 months in custody for his role in the distribution of the Energy Wave.”

“Arthur had been previously warned by FDA agents in 2010 that the devices that he was manufacturing were not approved by the FDA and were therefore considered to be illegal medical devices which could not be marketed without FDA approval and his registration as a manufacturer.”   

Compliance for Dummies

This week’s guidance examines stupidity at its absolute peak with the sentencing of David Arthur to prison. This rocket scientist was told not once, but twice, to cease and desist by FDA, including a previous felony conviction for his corporation (CNGI) for selling violative devices. Instead of learning from his legal missteps with FDA, Arthur waited a few months, renamed the previously identified violative devices, and began selling them again without benefit of registering as an establishment or obtaining FDA clearance. The second time around, FDA gave Arthur an additional warning, but Dr. D thinks it fell on deaf ears, as this individual again ignored the agency’s warning that the devices were being entered into commerce illegally.

Folks, the doctor cannot place enough emphasis on what the FDA means when it tells an establishment to stop selling violative product. Stop means stop. It surely does not mean to stop once targeted sales revenue is achieved. Additionally, there is never going to be an acceptable excuse for failing to register as an establishment with the FDA, when an organization has designed, developed, and plans to introduce into commerce a finished medical device in the United States—even if the device is a magical contraption such as the “Energy Wave” sold by Arthur.

According to the DOJ press release, the Energy Wave could cure a multitude of disease states, including worm infections. What in the heck is a worm infection? Is it the worm (actually larvae) found in the bottom of a bottle of Mezcal infecting the individual that gets to polish off the bottle and wins the reward of worm infestation? Regardless, dial up a frequency with Energy Wave and the cure is imminent. As the doctor writes this week’s DG, he is wondering if this machine has some really cool therapeutic uses, such as curing hangovers. It could give new meaning to dialing up a cure (LOL). Seriously now, similar to registering as an establishment, regardless of class, all finished medical devices have to be listed (registered) with FDA. Can you say FURLS database? Now granted, Class II devices and Class III devices require additional review through either the 510(k) or PMA route. Everyone in industry knows one cannot just decide to manufacture and sell medical devices without first completing the appropriate steps with FDA. Otherwise, you may be sharing a cell with David Arthur and his current cell mate (Ben Dover) at your local federal penitentiary, courtesy of DOJ.

Takeaways

For this week’s guidance, Dr. D will leave the readers with just one takeaway: Please do not be the next David Arthur. If you are your establishment’s CJO, make sure your registration establishment fees are paid by December 31 (each year). Additionally, make sure all of your establishment’s finished medical devices have been appropriately classified, cleared or approved, and listed in FURLS. Why? Just ask David Arthur. I understand he has 18 reasons for not making the same mistake again, in the form of 18-months of incarceration. 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.(October 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. “October 5, 2015: Manufacturer of Unapproved Medical Devices Sentenced to 18 Months in Prison”. Accessed December 7, 2015. Retrieved from: http://www.fda.gov/ICECI/CriminalInvestigations/ucm467863.htm