The Food and Drug Administration recently issued a guidance to clarify when a change to a device constitutes a recall, distinguish a recall from an enhancement, and clarify the reporting requirements under 21 Code of Federal Regulations Part 806.
The guidance serves to clarify the Food and Drug Administration’s thinking about what constitutes a recall and what constitutes an enhancement.
Per the guidance, a recall occurs when a manufacturer removes a device that it considers to be in violation of regulations. The firm identifies a defect, determines that a recall is necessary, and goes through the recall process to remove it from the market.
The guidance also distinguishes devices in violation of the regulations from devices in compliance with the regulations. According to the guidance, devices in violation of the regulations are distinguished from devices in compliance of the regulations by whether the recall is intended to correct a defect that would affect its ability to perform as specified, if the labeling is false or misleading, or if other regulations are not being met.
The guidance clarifies the Food and Drug Administration’ s thinking on what constitutes a device enhancement. Device enhancement is not defined by the Federal Drug and Cosmetic Act or laws enacted by the Food and Drug Administration. However, per the guidance, an enhancement occurs when the device is not in violation of the regulations. Some examples include upgrading software or making changes to include the sensitivity of a test.
Several factors influence whether a manufacturer needs to use the recall mechanism. The first consideration is whether the product is a device. If it meets the definition of “device,” it may be recalled, as opposed to undergoing stock recovery or some other withdrawal. If not, it is subject to withdrawal under another mechanism.
The second is whether the manufacturer is considering correcting or removing a device. If the manufacturer is not performing a device correction or removal, a recall is not necessary. An enhancement would meet this criterion.
Whether a recall is necessary depends on what the defect is. If the defect is minor, manufacturer can perform a market withdrawal to correct the defect. This defect would not be subject to legal action by the Food and Drug Administration and does not require a recall.
If the manufacturer needs conduct standard maintenance, a recall would not be necessary.
The third is whether the device is currently marketed. A device that is not currently marketed does not undergo a recall. Instead, it undergoes stock recovery, during which a manufacturer removes an unmarketed device or one that the manufacturer does not directly control.
If it has not been reported according to 21 Code of Federal Regulations Parts 803 or 1004, a recall must be reported under 21 Code of Federal Regulations Part 806.
Some criteria include a device with a defect that poses a serious health risk, such as risk of death or other temporary or permanent adverse consequences. If the adaptation is only an enhancement, the manufacturer does not need to file an 806. Manufacturers should submit an 806 within ten working days of initiating the recall.
The guidance does not address whether a Premarketing submission is required. It also does not apply to radiation-emitting devices, and it does not discuss methodologies for risk management or assessment. However, it does help the manufacturers to distinguish whether a recall is necessary.
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