Devine Guidance

Try Obtaining Clearance First, Dudes

By Dr. Christopher Joseph Devine

When in doubt about determining the correct device classification, it is always best to contact someone that actually has a thorough understanding of the regulations. In fact, you can even contact FDA.

Seriously, a company decides to just start selling a medical device on the U. S. Market without obtaining FDA clearance in advance? Seriously, a company actually believes that they can get away with selling unapproved medical devices indefinitely? 

Ladies and gentlemen, the doctor would like to remind folks that FDA will eventually catch up with these organizations. Trust the doctor when I say, potential competitors that are playing by the rules or in this case 21 CFR, Part 807 will glad contact the agency if they know a competitor does not have clearance to market and distribute a product in the United States. For those rocket scientists that haven’t figured out the various regulations, if an unapproved (not cleared) device starts racking up MDRs, rest assured FDA will eventually find out on their own, as will attorneys looking for a quick score. Dr. D’s experience with the agency leads me to the conclusion that they can never be accused of acting “pusillanimously” (look-it-up). 

Warning Letter – 15 January 2014

“A review of our records reveals that your firm has not received premarket clearance or approval to market these devices in the United States, which is a violation of the law. Therefore, the UltraSlim and Luxurian 150 lighting systems 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 investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g).  The UltraSlim and Luxurian 150 lighting systems are also misbranded under section 502(o) 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, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).”  

“Your firm should take prompt action to correct the violations addressed in this letter.  Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice.  These actions include, but are not limited to, seizure, injunction, and civil money penalties.  Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.”  

What does it all mean Dr. D?

Simply put, the agency showed for a cup of coffee and hopefully stated in a politically correct manner, “Cease and desist or else bad thing are going to happen.” Seriously, premised on the content of the warning letter, the agency expects this organization to stop the advertising and sale of these misbranded products immediately. In fact, this organization should quickly add a new phrase to their vocabulary; “Class I Recall!” Why? Because the FDA is going to expect these good folks to begin recovering all product determined to be misbranded ASAP!

However, the Chief Jailable Officer (CJO) can always choose to ignore the FDA’s warning letter. Probably not a smart move since FDA will respond accordingly. In fact, the doctor will let the readers pick the appropriate poison: (a) product seizures; (b) injunctions; (c) civil penalties – a.k.a., fines; (d) consent decree; and/or (e) an all-expense-paid trip to Fort Leavenworth, Kansas (wearing a new orange jumpsuit and shiny bracelets).

Conversely, the pragmatic approach would be to script and submit the 510(k) to FDA for review and approval. Is this manufacturer going to lose some significant coin? You betcha hey; however, once the offending devices are properly cleared and the offending manufacturer returns to the good graces of FDA, the interrupted revenue stream will once again start to flow.


For this week’s guidance, the doctor will leave the readers with just one takeaway. When in doubt about determining the correct device classification, it is always best to contact someone that actually has a thorough understanding of the regulations. In fact, you can even contact FDA. They will get back to you with an answer. It may not be the answer you are looking for but it will be an answer. If you already know a device is going to be a Class II or Class III, then why wait? Dr. D recommends assembling the 510(k) or PMA right away.

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. 


  1. Code of Federal Regulation. (2013, 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. Warning Letters – Inspections, Compliance, Enforcement, and Criminal Investigations. (2014, February). Retrieved February 3, 2014, from

About The Author

Dr. Christopher Joseph Devine, President, Devine Guidance International