As most device industry professionals already realize, when the FDA sends an inquiry, they probably are going to expect a response. For this week’s guidance, Dr. D came across a recently issued warning letter that cited on two occasions, that the FDA failed to receive a response from the offending establishment. Ouch! You might as well give the Chief Jailable Office a sharp stick and place this individual into a cave with instructions to poke the first bear seen, in the eye, with a sharp stick. In any event, whether a ticked-off bear or a ticked-off FDA, things are going to end badly. Maybe it was just some strange abulia (look-it-up) that prevented the management team from this week’s offending establishment from responding to FDA. Regardless, the offending establishment was rewarded with a prized agency warning letter. Enjoy!
Warning Letter – 13 July 2015
What the doctor finds somewhat ironic about this warning letter is that there were multiple quality compliance issues noted at two different manufacturing facilities. However, the individual plants were able to quickly provide responses to the quality system non-conformances on multiple occasions. However, why the offending device establishment would fail to address device clearance issues is a real mystery. Now granted, it is not uncommon to have disagreements with the agency over device class. Typically, these issues can be resolved with something called open and honest communications. Some even call this by its unique name, “dialogue”! However, silence, as previously alluded to in the title of this column, when failing to respond to an FDA inquiry is always going to end badly. Hey, maybe running from a ticked-off bear is the better option here versus complying with Part 807 requirements.
Observation One: “FDA has learned that your firm manufactures the Recovery Cone Removal System, Model RC-15 in the United States without marketing clearance or approval, in violation of the Act. Under section 201(h) of the Act, 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body. As explained below, this device is being marketed without the required clearance or approval.”
FDA Response: “Your firm has not submitted any correspondence to FDA regarding this violation to date.”
Observation Two: “FDA has also learned that your firm manufactures the Recovery Cone Removal System, Model FBRC in the United States without marketing clearance or approval, in violation of the Act. Under section 201(h) of the Act, 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body. As explained below, this device is being marketed without the required clearance or approval.”
FDA Response: “Your firm has not submitted any correspondence to the FDA regarding this violation to date. 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 C.F.R. 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.”
“FDA requests that Bard Peripheral Vascular immediately cease activities that result in the misbranding or adulteration of the Recovery Cone Removal System, Model RC-15 and the Recovery Cone Removal System, Model FBRC, such as the commercial distribution of the devices for the uses discussed above.”
Compliance for Dummies
Now granted, Dr. D was not present when FDA issued the warning letter, and the doctor was not involved in any of the agency discussions. In fact, the doctor is betting that neither were most of the readers. That being said, it is difficult to comprehend what the CJO(s) were thinking with their failure to address the agency’s clearance concerns. Considering the current state-of-the-art associated with communication tools—a letter (sent registered or certified, of course); an email; a fax; picking up the phone; sending a tweet; or even the use of a carrier pigeon (just kidding on the tweet and the pigeon)— talking about the device clearance issues with FDA may have been sufficient enough to ward off the warning letter. However, as mentioned, “silence is not always golden.” This is especially true with FDA.
The best advice the doctor can offer is to promptly respond to all agency inquiries. In fact, the acronym “ASAP” should be on top of every CJO’s acronym list. Please remember that the response provided to the FDA for any inquiry should always be succinct and complete. However, it should never be late. Otherwise, picking up that sharp stick and taking up the dangerous hobby of poking a bear in the eye just might be a preferred option.
For this week’s guidance, the doctor will leave the readers with just one takeaway: There will never be a valid reason for failing to respond to an FDA inquiry. Repeat after Dr. D, “Never, never, never, and never” will there be a valid reason for failing to respond to an agency inquiry. Failing to respond to FDA is equivalent to opening Pandora’s Box, a.k.a., increasing regulatory pain beginning with a warning letter. CJOs of the world, the choice is yours: Regulatory compliance or a sharp stick and a ticked-off bear. 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.
- Code of Federal Regulation. (2014, April) Title 21 Part 807: Establishment registration and device listing for manufacturers and initial importers of devices. Washington, D.C.: U.S. Government Printing Office.
- Code of Federal Regulation. (2014, April) Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation –21 CFR, Part 820. Charleston, SC: Amazon.
- Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
- FDA’s enforcement page. (July 2015). Accessed July 28, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm455224.htm