Devine Guidance


By Dr. Christopher Joseph Devine

The concept of detention, employed by FDA, is not unlike the pain associated with the after school detention of this doctor’s wayward youth.

This week Dr. D will briefly discuss detention. Now as a youngster, the doctor was well-versed in the virtues of detention as Dr. D spent hours upon hours thinking about the need to correct one’s behavior. Sorry Mr. Principal, I did not think putting some Ex-lax in my teacher’s coffee was a big deal. The doctor was only trying to prove a point in biology class.

Seriously folks the concept of detention, employed by FDA, is not unlike the pain associated with the after school detention of this doctor’s wayward youth. The principal places you in a room and you cannot leave. However, the FDA’s pain will hit a device manufacturer squarely in the pocket.

In searching through FDA’s warning letter database for this week’s guidance, the doctor came upon a recent letter issued to Lucky Board Manufacturing. Unfortunately, Lucky Board Manufacturing just may be contemplating a name change to “Unlucky” Board Manufacturing. You see, Lucky has been manufacturing and selling surgical masks without one minor little detail; they lack pre-market approval as required by the Act. Now granted, surgical masks can be categorized as a “fungible” (look-it-up) commodity; however, approval/clearance is still required to enter these devices into commerce in the United States. Just maybe, someone at Lucky might want to consider reading 21 CFR, Part 807.

FDA Warning Letter Issued on June 20, 2013
Given the serious nature of the violations of the Act, surgical masks manufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA may take steps to refuse these products, known as “detention without physical examination,” until these violations are corrected.  In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you if your firm’s response appears to be adequate, and we may need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
For this week, the doctor will be brief. FDA retains the right to seize and place into detention adulterated product, including the refusal to admit violative products into the United States. Our good friends at Lucky will need to satisfy all of the concerns noted in the warning letter, including the filing of a pre-market application for their device, to once again fall within the good graces of the agency. Please keep in mind, the process of correcting a warning letter is not cheap. Not only are the dollars or in this case the Yuan, going to quickly add up, but the lost revenue from sales in the United States is going to severely impinge upon this organization’s bottom line.

Additionally, the warning letter mitigation process is time consuming. For all of you wannabe CFOs out there, time equates to money. Duh, real rocket science from Dr. D. Seriously, warning letters are not resolved in a few days, a few weeks, or even a few months. Depending on the organization’s response and commitment, a warning letter could take a year or even longer to correct. I would think detention or the threat of detention would be sufficient to correct the behavior of noncompliance. Heck it worked for the doctor as a high school student.

For this week’s guidance, Dr. D will leave the readers with one takeaway. FDA wields an incredible amount of power when it comes to enforcing compliance to the Act. Detention is just one of the tools in the FDA’s tool chest. As a device industry professional, the doctor cannot fathom how a device manufacturer fails to acknowledge the need to obtain clearance from FDA for a device being introduced into commerce in the United States, regardless of the country of origin. Folks, remember only devices categorized as Class I exempt are “EXEMPT” from the pre-market approval process. Duh, you think!

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. (2012, 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. FDA – U.S. Food and Drug Administration Website. (2013, June). Warning letters. Retrieved July 14, 2013, from

About The Author

Dr. Christopher Joseph Devine, President, Devine Guidance International