Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Pins and Needles

By Dr. Christopher Joseph Devine
Dr. Christopher Joseph Devine, President, Devine Guidance International

Penetrating the skin introduces a different set of unavoidable safety and efficacy questions.

In many cases it is without question a challenging task to search through the listing of Class I (exempt) devices in search of the perfect predicate. Let’s face it, if a device establishment believes that it has correctly identified its device as Class I (exempt), they are going to run with it. While the Chief Jailable Officer (CJO) is doing the happy dance, a member of the regulatory team is entering the required device data into the FDA’s Unified Registration and Listing System (FURLS), as the sales team prepares to enter the new device into interstate commerce. However, what happens if the incorrect decision is made in regards to device class? Can you say warning letter?  Can you say misbranded and/or adulterated product? Believe Dr. D when he emphatically states, “This type of issue happens more often than CJOs would like to admit!” If you do not believe Dr. D, just ask the FDA. This week’s guidance dives briefly into a recently awarded warning letter and the vulnerary (look-it-up) remedies needed to close this regulatory wound opened by an FDA investigator. Enjoy!

Attend the Medical Device Recalls Conference | November 14–15, 2016 | Boston, MA | LEARN MOREWarning Letter – September 13, 2016

Dr. D can feel some of the pain the CJO on the receiving end of this warning letter must be experiencing. However, when little tidbits of information such as “micro-needling technology” or “designed for use by licensed healthcare practitioners” are noted by FDA investigators, Dr. D believes (purely conjecture on the part of Dr. D, mind you) the investigators begin looking for the 510(k) or PMA used to obtain device clearance or approval. Now granted, there is a plethora of Class I devices that may appear to be a higher classification because of the technology involved or a perception of implied risk, that are in fact just a Class I device. However, needles usually imply breaking the skin. What happens when a puncture wound to the skin is induced? If you said a trickle of blood appears, you would be correct. If the patient is a hemophiliac, maybe more than just a little a little blood might flow. Regardless, once the FDA has established that needles are penetrating the skin, a series of new safety and efficacy questions need to be resolved. Answering these types of product safety and efficacy questions usually elevate a device to a higher device class.

Warning Letter Excerpt

“Our inspection, and review of materials collected during the inspection, revealed that the SkinPen II is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do 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 SkinPen II is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because you did not notify the Agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the Agency.  21 CFR 807.81(b).  The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html.  The FDA will evaluate the information you submit and decide whether your product may be legally marketed.”

“Specifically, FDA has reviewed product labeling for the SkinPen II, including your firm’s websites located at http://bellusmedical.com/products/skinpen, http://skinpen.com/ and https://www.youtube.com/watch?v=zWRwhi9Yjrc, brochures, and pamphlets, which revealed that the SkinPen II is an automated, non-surgical microneedling technology device designed for use by licensed healthcare practitioners or individuals directed by practitioners. The device is a microneedling device intended to improve the appearance of fine lines, wrinkles and scars on the face and body by delivering thousands of micro-injuries to the skin to initiate the body’s wound healing process.”

Compliance for Dummies

There are a few vulnerary remedies that can be used to actually prevent these types of regulatory wounds from occurring. For example, when in doubt of the potential device classification for a new product, a device establishment can actually reach out to the FDA and ask for their assistance (opinion). The CJO can call or send an email, and the FDA will get back with a response. Now granted, the CJO may not like or agree with the agency’s response, but the response just might keep the CJO and the establishment they represent out of the FDA’s warning letter doghouse. As the medical device industry becomes increasingly complex in the United States, relying on FDA input is some of the best free advice Dr. D can offer.

Learn best practices for recalls at the Medical Device Recalls Conference | December 5–6, 2016 | Schaumburg, IL (Chicago) | LEARN MOREIf you are a CJO on the receiving end of a prized agency warning letter, “tick-tock” baby, the clock is ticking. In fact, you have 15 days to formulate your response to FDA to prevent further escalation. Since we are talking about misbranded/adulterated product that the FDA strongly believes either a 510(k) or PMA is warranted, there is no time like the present to start compiling the documents and data needed to support a submission. If the offending devices have been entered into commercialization, there is no time like the present to give your establishment’s approach to device corrections and removals a workout. The doctor is quite sure if product corrections and removals is not part of your response to the FDA’s warning letter, they will fire one shot across the proverbial bow and then seek help from the Department of Justice courtesy of a product injunction and if deemed appropriate, product seizure and subsequent detention.


For this week’s guidance, the doctor will leave the readers with just one takeaway: If your establishment is unsure of the correct device classification (e.g., Class I versus Class II), it is okay to reach out to FDA for assistance. Ultimately, establishments may not agree with FDA; however, it is better to abide by their classification decisions versus being on the receiving end of a warning letter. After all, it is the FDA’s sandbox, so they can make the rules. In closing, thank you again for joining Dr. D, and I hope you found 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. (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. (September 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Bellus Medical. Accessed October 12, 2016,  Retrieved  from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm520649.htm

About The Author

Dr. Christopher Joseph Devine, President, Devine Guidance International