For this week’s guidance, Dr. D is going to switch it up just a bit and dive into the doctor’s favorite six-letter word “RECALL.” For those of you that have grown a little long in the proverbial tooth while working in the device industry, you are well-aware of our friend Murphy just waiting to pop up an raise his ugly head. When Dr. D’s old friend Murphy decides to make that grand appearance, it is inevitable that bad things are about to happen, including the need to pursue a product correction or removal (a nice way of saying recall). If your establishment finds the need to execute a Class I recall, the chances are pretty good our friends from the agency are going to appear on your establishment’s doorstep for a cup of coffee and an inspection. If your establishment is racking up multiple Class II recalls, you better keep the pot of coffee on the burner.
However, if an establishment is executing corrections and removals and failing to notify FDA, then rest assured, a warning letter is in your establishment’s future; and no crystal ball is required to see into the future. For this week’s guidance, Dr. D will explore what happens to a device establishment that fails to notify FDA when corrections and removals occur. The “nabobs” (look-it-up) at the agency were seriously not impressed with this establishment’s failure to notify them of field actions they were pursuing; and as a result something really bad happened, a warning letter.
Warning letter – 17 November 2014
Folks, fail to notify FDA of a correction and removal, and bad things will happen, regardless of how benign a correction or removal may appear to be. If the correction or removal is driven by finished medical devices hurting users and patients, then it is incumbent upon the manufacturer to act immediately. Devices should always be safe and effective in their intended use. However, it just might be nice if someone in the organization picks up the phone, calls their local FDA office, and notifies them of the pending correction or removal.
If it is a minor correction or a Class III recall, keep meticulous records as an investigator will want to review these records during an inspection. If the recall is categorized as a Class I or Class II, you better brush up on Part 806 and start providing FDA with “ALL” of the information required by the regulation. Regardless, the common thread here is establishments are required to report “ALL” corrections and removals to FDA. As you will quickly see, this week’s offending establishment failed to notify FDA on six (6) separate occasions that corrections were occurring. As a result, they were rewarded for their efforts with a Warning Letter. Congratulations!
Warning letter excerpt
“Failure to report to FDA in writing a correction or removal, conducted to reduce a risk to health posed by a device, as required by 21 CFR 806.10(a).
Specifically, from November 29, 2011, through June 3, 2014, your firm performed six corrections in the field on the integrated heating element or other components that comprise your Serenity treatment chairs. The corrections have been performed via heat service kits being installed “on demand” to address heating element malfunctions, such as overheating, which causes burns on the chair and/or patient, or other heating element complaints that have been reported by multiple complainants since 2011.”
21 CFR, Part 806 – Subpart B – Reports and Records
Section 806.10 Reports of Corrections and Removals
(a) Each device manufacturer or importer shall submit a written report to FDA of any correction or removal of a device initiated by such manufacturer or importer if the correction or removal was initiated:
- To reduce a risk to health posed by the device; or
- To remedy a violation of the act caused by the device which may present a risk to health unless the information has already been provided as set forth in paragraph (f) of this section or the corrective or removal action is exempt from reporting requirements under 806.1
(b) The manufacturer or importer shall submit any report required by paragraph (a) of this section within 10-working days of initiating such correction or removal.
Compliance for Dummies
For this week’s guidance, Dr. D will be brief. How brief? Dr. D will be one paragraph brief. When your organization establishes their SOP for recalls and procedures, please feel free to steal from Part 806. In fact, steal line-by-line if you must. As part of this week’s guidance, the doctor will cover two of the more important elements associated with Part 806; 806.10(a) and 806.10(b). These two components of the regulation entail: (a) the initial notification made to FDA that a correction or removal is about to occur; and (b) that the notification shall be made within 10-working days.
For those of you that are actually paying attention, Dr. D did use the phase; “about to occur” in the previous sentence. You definitely want to notify FDA in advance of executing a correction or a recall. Why? Let’s say your product is in high-demand and an unexpected withdraw could have a serious impact on the public health, the agency will want to discuss replenishment plans in detail. If an establishment fails to have an adequate back-up plan; you can take it to the proverbial bank, the agency will be notifying potential suppliers (a.k.a., your competition) about the need to produce more devices quickly as there is about to be a significant shortage of devices in the market.
Word of a recall does travel fast in this industry; and as a result, astute healthcare providers are already on the phone calling your competitors. Ouch! Regardless, to comply with 806.10(a) and 806.10(b) device manufactures must notify FDA within 10-working days of any correction and removal. Compliance does not get any easier than this folks.
For this week’s guidance, Dr. D will leave the readers with two takeaways. One – establishments must notify FDA of all corrections and removals (806.10(a)). Two – notification of all recalls and removals must occur within 10-working days (806.10(b)).
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 806 medical devices; reports of corrections and removals. 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. (2014, November). FDA.gov Website. Retrieved December 16, 2014, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm423254.htm.