Medical device corrections and removals (a.k.a. recall, Dr. D’s favorite nasty six-letter word) are never fun events. They tend to be upsetting to the end user (healthcare providers & patients) and the device establishments needing to execute the appropriate actions in accordance with 21 CFR, Part 806. If a company fails to execute a correction or removal in accordance with Part 806 or fails to notify the FDA when such activities occur (Class III recalls excluded from notification), bad things will happen to the offending establishment. Part 806, coupled with Part 7 (Enforcement Policy) and Part 810 (Medical Device Recall Authority), provides sufficient granularity in regards to the notification process and the data needed to remain in compliance. However, recall classification tends to be an issue as device establishments struggle with the decision of when to notify (hopefully within 10 days) our dear friends from the agency. The best practice (Dr. D’s humble opinion) is to contact your local FDA district office and discuss a pending correction or removal. It is imperative that FDA agree with the recall classification, which in turn drives the notification requirement. For this week’s guidance, Dr. D will provide some insight into corrections and removal, and provide a recent warning letter that clearly reflects an agitated FDA when they are not notified of a correction or removal. The Chief Jailable Officer (CJO) is not going to be a happy camper, being on the receiving end of a warning letter that contains 10 Form 483 Observations. Ouch! Ten observations are enough to give any CJO nightmares, especially when it comes to developing a cohesive plan for mitigating the observations. When our dear friends from the agency appear in a device establishment’s lobby for that friendly cup of coffee and an inspection, not having a quality management system (QMS) that fully complies with the quality system regulation (QSR) requirements will adumbrate (look-it-up) everything to come, including that prized agency warning letter. Enjoy!
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The establishment mentioned in this week’s guidance was on the receiving end of a 10 Form 483 Observations warning letter. Now granted Observation 10, which deals with corrections and removals, was probably not the deciding factor in the issuance of the warning letter, but managed to grab the doctor’s attention. Typically, any establishment receiving double-digit Form 483 observations during an inspection is in danger of being awarded one of the highly prized agency letters. However, on occasion, a well-worded response that is accompanied by documented evidence of correction will result in no additional regulatory action pursued by FDA.
Warning Letter Excerpt
Observation Three (10) – “Our inspection further revealed your firm’s Remote patient monitoring devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), as your firm failed or refused to furnish material or information regarding the device, as required by section 519 of the Act, 21 U.S.C. § 360(i), and 21 CFR 806 – Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:
10. Failure to submit a Report of Correction or Removal of a device initiated to reduce a risk to health posed by the device, as required by 21 CFR Part 806.10. For example:
In June 2015, your firm received a complaint, from a customer, that a patient monitor locked up and recycling the power was the only way to restart. In July 2015, a second customer with 16 units notified your firm that the first installed unit froze up and had to be powered off to resolve. The cause was the same as the lockup at the first customer. On July 18, 2015, your firm shipped the second customer a loaner unit, with corrected Rom Monitor, that prevented continuous traps to prevent lockups. On August 7, 2015, your firm went to the second customer to update all 16 units with interim mitigating software. FDA was not notified of a correction until November 2015.
Your firm’s action has been reviewed and determined by FDA to meet the requirement of a Class II recall (Recall No. Z-0582-2016), which also meets the threshold for a 21 CFR 806 report, as specified in 21 CFR 806.2(k)(2). Therefore, your firm’s actions should have been reported to FDA for Correction or Removal of a device initiated to reduce a risk to health posed by the device, as required by 21 CFR 806.10(a)(2).”
21 CFR, Part 806.10 – Reports of Corrections & 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:
(1) To reduce a risk to health posed by the device; or
(2) 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 the reporting requirements under 806.1(b).
(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.
Please note, this is only a partial reprint of §806.10. The entire regulation can be obtained by visiting the FDA’s website.
Compliance for Dummies
As the doctor previously mentioned, when in doubt, it is an acceptable practice to contact FDA and obtain their concurrence when a correction or removal is in the works. Please keep in mind, the FDA does not like surprises. If the correction or removal activity requires the updating of software to reduce the risk to patient, the activity is deemed worthy of reporting to FDA as a Class II recall. Dr. D recommends that the readers take some time and glance at 21 CFR, Part 7 and 21 CFR, Part 810 for additional guidance.
The FDA has identified three classes of recalls that are designated by the Roman Numerals I, II, and III. The concept is premised on risk, with Class I being the highest risk and Class III being the lowest risk. The agency’s definitions for each recall class are as follows:
- “Class I – a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
- “Class II – a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
- “Class III – a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”
The reason identifying class is so important is that the recall classification will also drive the notification process made to the FDA. Class I and Class II requires that FDA be notified of the recall (10 days, baby and the clock is ticking), including updates, while maintaining meticulous records associated with the recall. Class III requires that device establishments maintain recall records and have them available for review during an agency inspection.
As previously mentioned, the FDA expects device establishments to maintain meticulous records when it comes to recalls. Additionally, the FDA wants to ensure device establishments actually have some success in recovering suspect devices. Just notifying customers of the recall without a serious attempt made to recover product is viewed as being problematic by the agency. Now granted, healthcare professionals can decide to ignore the recall and throw caution to the wind premised on a practitioner’s medical knowledge. However, the risk of litigation due to potential patient injury is typically not worth the risk.
Please keep in mind, there are many moving parts associated with a recall. That being said, the FDA has provided guidance on the basic elements of a recall:
- Completion of a Health Hazard Evaluation form (use FDA’s version as it is free)
- Correct identification of the recall classification
- FDA notification – required for Class I and Class II recalls (within 10 days)
- Scripting of the recall strategy (including effectiveness checks)
- Scripting of the recall letter
- Recall status reports
- Notifying the FDA when a recall has been completed (recall termination)
For this week’s guidance the doctor will leave the readers with three takeaways. One: When in doubt of a potential recall classification, it is an acceptable practice to reach out to FDA for additional guidance. Two: For Class I and Class II recalls, make sure the agency is notified within 10 days. Three: Always keep meticulous records, regardless of recall classification. In closing, thank you again for joining Dr. D, and I hope you found value (and some humor) 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. (April 2016). Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
- Code of Federal Regulation. (2016, 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. (May 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. Vidco, Inc. Accessed. June 6, 2017. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm558078.htm