For those readers that may be long in the proverbial tooth, there used to be a television commercial back in the 70’s with the tag line; “It’s not nice to fool mother nature” For this week’s guidance, Dr. D would like to borrow and slightly modify the tag line to read; “It’s not nice to refuse requests from FDA.”

Seriously folks; the doctor always struggles when it comes to understanding how device establishments could be so off base with the understanding of regulatory and statutory requirements. FDA is very good at publishing regulations and guidance documents scripted for device establishments. In fact, a weekly visit to their enforcement page gives readers some insight into what issues FDA is focusing on during their inspections. An experienced Chief Jailable Officers (CJO) understands that running afoul of FDA is just not worth the “dyspepsia” (look-it-up) to be suffered for failure to comply with regulatory and statutory requirements enforced by the agency. However, failing to fulfill and agency request and/or bothering to obtain premarket approval or clearance prior to the placement of a medical device into commercialization; is always going to result in the FDA pursuing aggressive regulatory action. Enjoy!

Warning Letter – 12 February 2015

The level of ignorance associated with some device establishments and their failure to comply with statutory and regulatory requirements never ceases to amaze Dr. D. Now granted, on occasion device establishments can make poor decisions; however, the doctor does not understand how an establishment can decide refusing to give requested information to FDA or failure to obtain product approval or clearance from the FDA are sound decisions. In fact, the winner of this week’s prized FDA Warning Letter “failed or refused” to furnish material or information requested by the FDA. Seriously, the FDA visits a facility for a period of three weeks and a device establishment “failed or refused” to fulfill agency requests? What in the heck was the CJO thinking?

Seriously, there has to be a major disconnect for a device establishment to recognize the need to provide FDA with prompt responses and documented evidence of compliance during an inspection. Additionally, device establishments can always pick up the phone and ask their local FDA office about guidance on the need to receive approval or clearance for a medical device. Furthermore, ignorance is no excuse. If a device establishment does not have the regulatory expertise (as appears to be the issue here) there are qualified firms that can assist with writing the PMA or 510(k), as applicable. If this week’s warning letter recipient is using a consultant, they are clearly receiving bad advice or refusing to follow the advice being offered. Regardless, now this establishment has to navigate through the often treacherous waters associated with warning letter mitigation.

Warning letter excerpt

“Our inspection revealed that your firm’s Medical Device Cleaning and HLD Washer/Pasteurizer System Model 610 device is misbranded under section 502(t)(2) of the Act [21 U.S.C. § 352(t)(2)], in that your firm failed or refused to furnish material or information respecting the device, as required under section 519 of the Act [21 U.S.C. § 360(i)], and Title 21, Code of Federal Regulations (CFR) Part 806 – Medical Devices; Reports of Corrections and Removals.”

“Our inspection also revealed that your Medical Device Cleaning and HLD Washer/Pasteurizer System Model 610 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)]. Your Medical Device Cleaning and HLD Washer/Pasteurizer System Model 610 device is also misbranded under section 502(o) of the Act [21 U.S.C. § 352(o)], because your firm did not notify the agency of its intent to introduce the device into commercial distribution in that a notice or other information respecting the modification to the device was not provided to the FDA as required by section 510(k) of the Act [21 U.S.C. § 360(k)], and 21 CFR 807.81(a)(3)(i) (requiring a premarket notification submission for a “change or modification in the device that could significantly affect the safety or effectiveness of the device….”).”

Compliance for Dummies

In support of addressing this week’s compliance issues, the doctor is going to provide the readers with two pieces of advice that all device establishments should clearly grasp. For starters, please keep in mind that when FDA shows up on an establishment’s doorstep for a cup of coffee and an inspection, they are visiting to collect evidence. When the agency determines that compliance issues exist, they write a famed Form 483 observation. The good news is device establishments do not have to reply to a Form 483 observation. The bad news is that failure to respond to a Form 483 observation (within 15-days) and the FDA will raise the level of regulatory pain by issuing a warning letter. Once a warning letter has been issued, the FDA is no longer inclined to review new product submissions or sign/approve Certificates to Foreign Governments (CFG). Why? Because in the eyes of the FDA, device establishments with documented compliance issues should be addressing those compliance issues versus worrying about their proverbial pipeline of new devices or their ability to ship finished medical devices outside of the US.

If the warning letter does not grab the attention of an offending device establishment, then product injunctions, detention holds for imported medical devices, US Marshals seizing misbranded and adulterated products, or even better, arriving with chains and padlocks will be the next regulatory level of pain pursued by FDA. Eventually, device establishments that just do not want to play nice in the FDA’s sandbox will find themselves in the federal courts discussing consent decree options with a federal judge and US Attorney. Folks, the options for failure to comply with regulatory and statutory requirements are not pretty and they only get uglier with time.

The second piece of advice Dr. D will offer is if a device establishment is unclear about the regulatory pathway for a new device, please contact FDA. The local office is a good place to start. Additionally, the FDA’s website contains a plethora of information that can be invaluable in a device establishment’s quest for commercialization of a new medical device. For example, if a device manufacturer is confident that their product is going to be a Class II, the following link will provide relevant information needed to facilitate the process: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm.

Takeaway

For this week’s guidance, the doctor will leave the readers with just one takeaway; “Don’t be the device establishment highlighted in this week’s guidance!” It is Dr. D’s humble opinion; the regulatory and statutory requirements needed to be a successful device establishment, in the United States, are clearly spelled out by FDA and available on their website. Ladies and gentlemen, there will never be an acceptable excuse defending the failure to provide FDA with requested data or just deciding to place product into commercialization without first receiving approval or clearance from FDA (most Class I device excluded).

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. (2014, 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’s enforcement page. (2015, February). FDA.gov Website. Retrieved March10, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm434867.htm.