As 2016 rapidly approaches, Dr. D would like to take the time and wish all of the readers a Happy and Prosperous New Year. In fact, 2015 flew by so quickly, the doctor’s head is still spinning—and that is not because of the mass quantities consumed over the holidays. I hope the readers have thoroughly enjoyed Dr. D’s quality and regulatory rants from 2015. Please remember, the doctor’s goal is to educate while at the same time entertain the readership, which is not always and easy thing to do. That being said, this final guidance of 2015 will take a brief look into what happens when a device establishment decides to expand its product portfolio without the benefit of obtaining FDA clearance. As indicated in the title, detention is not only bad for elementary and high school students (including Dr. D’s wayward-scholastic youth), but it is also very bad for medical devices. After all, FDA can never be accused of invidious (look-it-up) discrimination of device establishments. When an investigator magically appears, in a device establishment’s lobby for a cup of coffee and an inspection, the investigator will do everything in his or her power to conduct an impartial investigation. However, Chief Jailable Officers (CJOs) be warned: “There is no such thing as maximum compliance or minimum compliance, there is only compliance.” It is Dr. D’s favorite quote. Enjoy!  

Warning Letter – December 11, 2015

For this last guidance of 2015, Dr. D found another establishment willing to climb into the FDA’s sandbox but not willing to play by the agency’s rules. Now granted, when deciding if a new device is a product line extension or a design change is worthy of notifying FDA through either the 510(k) process or a PMA supplement, it is not worth the risk of making such important decisions unless you have rock-solid rationale or concurrence from FDA. It appears the winner of a prized agency warning letter (received earlier this month) decided they did not require agency buy-in. Unfortunately, the FDA clearly believes the decisions made by this establishment were bad ones. Marry the entering of finished medical devices into interstate commerce, without the benefit of obtaining FDA clearance, with a suspect quality management system (QMS), and a warning letter will be in the offending establishment’s future (no crystal ball required). In fact, either one of these agency sins will typically warrant the awarding of the prized agency warning letter. Provide the FDA with inadequate Form 483 responses and BINGO! The offending establishment wins the warning letter trifecta: (a) illegally entering product into interstate commerce, (b) non-compliant QMS; and (c) inadequate Form 483 responses. “I See a Bad Moon Rising” (thank you Credence Clearwater Revival for such a great song and so appropriate for this week’s guidance)!

Warning Letter Excerpt

Observation Three: “The FDA examined an imported shipment of Elite Massager Mono and Elite Massager Multi devices on November 4, 2015, at 1820 S. McDonald Street, McKinney, Texas, and detained the shipment on November 20, 2015. Our examination of the shipment revealed that Pressure Point Charts accompany the Elite Massager Mono and Elite Massager Multi devices. The Elite Massager Mono and Elite Massager Multi devices are 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 IDE under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the devices as described and marketed. The Elite Massager Mono and Elite Massager Multi are 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 these devices 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).”

“Your firm stated in its May 5, 2015 response that it would no longer include the Pressure Points Chart with its devices; however, FDA’s examination of the November 2015 detention of a shipment of Elite Massager Mono and Elite Massager Multi devices revealed that the Pressure Point Charts still accompany these devices.”

Compliance for Dummies

My dear readers, “when in doubt, always reach out”—meaning reach out to the FDA and ask. There really should never be any excuses made as to how or why uncleared or unapproved medical devices have found their way into interstate commerce in the United States. The FDA has really raised the bar when it comes to using the infamous “letter-to-file” rationale without the benefit of rock-solid evidence (scientific rationale) as to why agency review is not required. It appears that for some device establishments, there is a fine line between expediency (a.k.a. speed to market) and stupidity (failing to recognize that significant design changes warrant FDA clearance/approval). In any event, when CJOs make such reckless decisions, the outcome will eventually end up badly for the establishments they represent (I See a Bad Moon Rising).

The best advice Dr. D can offer in regards to product design changes, regardless of how benign such changes appear to be, is to have a qualified regulatory professional review and approve all changes. If your establishment does not have a full-time regulatory affairs professional, go find a qualified consultant. The stakes are just too darned high to “wing it”. As mentioned earlier, Dr. D is a big fan of contacting FDA when questions arise. Remember, only the investigators have teeth and occasionally bite (just kidding). Individuals at the agency, tasked with product reviews, will assist device establishments with making the correct decision.

As for issues associated with QMS procedures, generally they can be fixed quickly. However, it does take a competent staff or qualified consultant to help establish (define, document and implement) procedures. Additionally, most industry professionals are aware that Part 803 (Medical Device Reporting) has been through some minor agency tweaks over the past two years, such as UDI and eMDR requirements. Please keep in mind, when changes to regulations occur, the agency expects device establishments to revise their procedures accordingly. The doctor assumes that this advice may have fallen on deaf ears as the establishment referenced in this week’s guidance received multiple observations targeting their MDR procedure. People, when in doubt please steal from (plagiarize freely) the federal regulations. There is no need to reinvent the wheel. If a regulation contains the word “shall,” the FDA expects the requirement to be addressed within an establishment’s QMS.

Finally, providing the FDA with a less-than-adequate response to a Form 483 observation is based on one of three things:

1. The CJO preparing the response is incompetent
2. The CJO preparing the response is lazy
3. The CJO preparing the response did not understand the observation (do not be afraid to ask for clarification)

Regardless of the reason, if the responses to Form 483 observations are deemed to be inadequate, then bad things are going to happen to the offending establishment (I See a Bad Moon Rising).

Takeaways

For this week’s guidance, the doctor will leave the readers two takeaways. One: Have a Happy New Year with your friends and family. Two: When in doubt, do not be afraid to reach out to FDA. The agency will try their darnedest to get you the correct answer. Having a CJO just winging it will always end badly (I See a Bad Moon Rising). 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 11, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Elite Massagers, LLC. Accessed December 26, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm477579.htm