Devine Guidance

FDA Issues a Warning Letter with no Plant Inspection! What?

By Dr. Christopher Joseph Devine

If your establishment is planning to introduce a medical device into commerce, it is incumbent upon the organization to correctly classify the medical device and obtain the appropriate clearance/approval before offering the finished device for sale or advertising on your establishment’s website. Failure to do so will end badly.

Folks, since Dr. D’s bracket was irrevocably broken in the first round of this year’s Men’s NCAA Basketball Tournament, the doctor quickly became bored with watching college hoops on television and started scanning the FDA’s Warning Letter Database with a vengeance. That said being, the doctor found an extremely unique and rare warning letter event. Our friends from the agency issued a warning letter to an establishment because of advertising issues with their Internet website. Seriously, FDA did not magically appear on this establishment’s doorstep for a cup of java and an inspection. They issued a warning letter to this establishment for advertising what the agency believes should be a Class II device supported by the submission of a 510(k) in accordance with 21 CFR, Part 807. Not being familiar with this establishment’s products, Dr. D is not in a position to pass judgment; however, the FDA was quick to decide upon their “rhadamanthine” (look-it-up) judgment an issued a warning letter. Simply “STOP” and do not pass go or collect your $200. Seriously, the agency’s action was swift for this establishment’s transgression. Enjoy!

Warning Letter – 12 March 2015

As previously stated, Dr. D is not familiar with this establishment or their medical devices; however, the doctor is painfully familiar with the consequences associated with the making of bad decisions in the device industry. Obviously, one has to wonder if the FDA stumbled upon this Intent website issue on their own; or a ticked-off competitor made an anonymous call and pointed out this transgression. Regardless, the device establishment on the receiving end of the prized agency warning letter failed to do their homework. The end result is unleashing of some serious regulatory pain by the agency.

Warning Letter Excerpt

“The Food and Drug Administration (FDA) has reviewed your Internet website. Your website states that your Yes PRP Kit is an ““Easy and accurate PRP-Kit” for medical staffs.” Copies of the pertinent Internet website pages are enclosed for your reference.”

“The Yes PRP Kit is a medical device within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) in part because it is intended for use in the cure, mitigation, or treatment of disease. Your website describes the device as a kit for extracting blood from a patient, and preparing from that blood platelet rich plasma for re administration as a treatment for a number of conditions. Your device has an intended use similar to the intended use of previously cleared PRP devices under 510(k) premarket notification. The law requires that manufacturers of medical devices obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that medical devices are safe and effective or substantially equivalent to other devices already legally marketed in the United States.”

“A review of our databases disclosed that your firm has not obtained premarket approval or clearance for these Kit in the United States and has not received an investigational device exemption from premarket approval for these Kit either. Nevertheless, the Internet website above offers the Yes PRP Kit for sale to buyers in the United States. For example, the United States is included in the “drop-down” box on the contact page, inviting orders for shipment of the product within the United States. We also note that you include the FDA logo on your description of the product (linked to the phrase “in progress” in very small letters), which misleads the reader into concluding that your product is legally marketed in the United States. Because you do not have marketing approval or clearance from FDA, marketing these products in the United States is in violation of the law.”

Compliance for Dummies

Not wanting to state the obvious but obliged to do so, entering medical device into commerce in the United States requires the obtaining of clearance and/or approval by the United States FDA prior to the shipping of an establishment’s very first finished medical. For those of you familiar with the process, the FDA employs three device classifications premised on risk. Unless specifically noted, most Class I devices can placed into commerce in the United States after some simple steps are completed.

  • One – register as an establishment with the US FDA ($3,646 for 2015).
  • Two – list the device employing the FDA’s Unified Registration and Listing System (FURLS).
  • Three – ensure the appropriate Current Good Manufacturing Practices (cGMP) and supporting procedures, as required (i.e., complaint management, recalls, MDR, etc.).

Dr. D always recommends to my clients to just bite the bullet and implement a Quality Management System that is in compliance with 21 CFR, Parts 801, 803, 806, 807, and 820 requirements. It may sound like a lot but it really isn’t. Additionally, the doctor finds that labeling compliance with Part 801 is often overlooked. However, with the FDA’s ongoing push for Unique Device Identifier (UDI) compliance, the importance of product labeling cannot be understated.

For Class II devices (with very few exceptions), a 510(k) prepared in accordance with Part 807 is a salient requirement. A tiny little point this week’s warning letter recipient appeared to have overlooked. The doctor is just not sure what the Chief Jailable Officer (CJO) might have been thinking about when the advertising of a medical device that was not properly cleared was presented on this establishment’s website. Oops! When in doubt, a quick call to the FDA’s Orlando District Office just may have resulted in the avoidance of a warning letter.

For Class III devices, the regulatory pathway is through the submission of a Premarket Approval (PMA) application with all of the pallets full of clinical and supporting documentation. Dr. D recommends that device establishments planning to introduce Class III device into commerce become familiar with Part 814.


For this week’s guidance, the doctor is going to leave the readers with just one takeaway. Folks, please employ some common sense. If your establishment is planning to introduce a medical device into commerce, it is incumbent upon the organization (hint, hint, CJOs) to correctly classify the medical device and obtain the appropriate clearance/approval before offering the finished device for sale or advertising on your establishment’s website. Failure to do so will end badly, just ask the warning letter recipient highlight in this week’s guidance.

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. (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). Website. Retrieved March24, 2015, from

About The Author

Dr. Christopher Joseph Devine, President, Devine Guidance International