As an experienced FDA medical device investigator, at one time or another, many firms I inspected struggled with deciphering FDA regulations and would misinterpret 21 CFR 806 (http://bit.ly/21CFR806-Recall). Fortunately, FDA 483 inspection observations can be easily avoided by doing two things. First, personnel responsible for corrections and removals need proper training—not just “read and understand.” Second, your forms and procedures need to comply fully with 21 CFR 806. The following is a list of 5 common mistakes made that are related to 21 CFR 806:
- incorrect interpretation of recall exemptions
- misinterpretation of reporting and documentation requirements
- failure to comply with recall reporting timelines
- failure to properly classify a recall
- insufficient recall training for quality personnel
21 CFR 806.1(b) – Recall Exemptions
The section of the regulations that deal with recall exemptions, 21 CFR 806.1(b), is the most widely confused interpretation. There are four categories of exemptions from correction and removal reporting:
“actions were taken by device manufacturers or importers to improve the performance or quality of a device, but that does not reduce a risk to health posed by the device or remedy a violation of the act caused by the device.
Market withdrawals as defined in 806.2(h).
routine servicing as defined in 806.2(k), and
stock recoveries as defined in 806.2(l).”
The risk to health is referenced in 21 CFR 806.1(b)(1) and has two definitions. The first is easily interpreted when there is a reasonable probability that the use or exposure of a medical device could cause serious adverse health consequences or death. Part 2 is confusing in that the definition states that a risk to health can be considered a temporary or medically reversible adverse health consequence, or the possibility of serious adverse health consequences is remote. The second part of the definition of “risk to health,” is not clarified in the recall regulations. Still, you can refer to 21 CFR 803.3 (Medical Device Reporting definitions) for the definition of “serious injury”:
- an injury or illness that is life-threatening,
- results in permanent impairment of a body function or permanent damage to a body structure, or
- necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
21 CFR 806.10 – Reporting & Documenting FDA Recalls
This section, 21 CFR 806.10 (http://bit.ly/Reporting-FDA-Recalls), is frequently misinterpreted. Corrections and removals by manufacturers and importers require reporting to CDRH, but there are two conditions. Either of the following conditions requires reporting 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 outlined in paragraph (f) of this section or the corrective or removal action is exempt from the reporting requirements under 806.1(b).”
It is usually better to err on the side of caution and report the correction and removal, but in all cases, properly document your rationale for reporting or not reporting.
21 CFR 806.10(b) – Recall Timelines
Reporting of corrections and removals requires the firm to report these recalls to FDA within ten days. Timeframes are important, so the information can be disseminated to the Regional and District Office after notifications are made to the FDA.
21 CFR 7.3(m) – Recall Classification
Even when manufacturers and importers file a recall report within the specified timeframes, many times, the recall is improperly classified. Many manufacturers fail to classify their correction and removal based on severity properly. As reported by the FDA in 2013, a study (http://bit.ly/CDRH-Recall-Report) was conducted by CDRH on reported recalls, and this explanation of recall classifications was provided:
“As defined at Title 21, Code of Federal Regulations (CFR), 7.3(g), ‘Recall means a firm’s removal or correction of a marketed product that the Food and Drug Administration considers being in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure.’
- A Class I recall is 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.
- A Class II recall is a situation in which the 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.
- Also, a Class III recall is a situation in which the use of, or exposure to, a violative product is not likely to cause adverse health consequences.”
Insufficient Training on FDA Recall Procedures
Each year, the FDA emphasizes the need for investigators to determine that each firm under the FDA area of jurisdiction properly maintains “Recall SOPs,” provides training on these procedures, and fully implements them. When your company performs an initial review of a recall procedure, or the recall procedure is re-written, a systematic review of each element in the regulations is needed. When you perform this review for your Recall SOP, ensure that you verify each of the first four common mistakes are addressed. You should also consider creating an exam to verify the effectiveness of training (http://bit.ly/TrainingExams). If your company manufactures or imports radiologic devices, ensure that the special requirement below is included in your procedure.
Special Requirement: Radiation Emitting Devices
Radiation emitting devices, such as medical lasers, X-Ray, and UV emitting devices, hold another special requirement seldom observed by the CDRH Compliance officers and FDA investigators that are not fully trained in radiation-emitting devices. If a medical device manufacturer or importer becomes aware of a defect in any radiation-emitting device that could cause serious injury, death, or require medical intervention to preclude serious injury or death, this defect must be reported to FDA under 21 CFR 1003. This regulation is one of the few FDA regulations that have significant teeth to mandate each manufacturer or importer to “Repair, Replace or Refund the purchase price” of the device when the manufacturer becomes aware of a major defect in their device (21 CFR 1004). This applies to medical and non-medical radiation-emitting devices, both of which are under FDA jurisdiction.
In some extreme cases, when I observed major defects in a medical device that also included a radiation-emitting device as well, if the CDRH Office of Compliance was unwilling to require a recall of the device, the recall could be mandated by the CDRH Division of Enforcement B (http://bit.ly/CDRH-Divisions-and-Offices). Division of Enforcement B has responsibility for enforcement of medical device regulations to radiologic devices.
Medical Device Academy recorded a webinar on the topic of FDA recalls. You can purchase the webinar by clicking on the following link: http://bit.ly/FDA-recalls-webinar.