Last year the FDA issued a draft guidance to clarify the difference between a recall and a product enhancement. Only voluntary recalls are in scope and whether they are performed by the manufacturer or at the request of the FDA is irrelevant. The difference is important as a recall requires the submission of a correction and removal report to the FDA. These reports become part of public record and thus may not put the company in a positive light. What may be considered recalls can include updates to instructions or changes to components or labeling.
Not That Explicit
A recall removes or corrects products from distribution that are in violation of the law and therefore the FDA could initiate legal action. These are typically a voluntary action by the manufacturer, but in rare instances, the FDA may issue a recall order.
A market withdrawal is the removal or correction of a distributed product with a minor violation that is not subject to legal action by the agency.
So the big question on the table is what constitutes a major from a minor? The manufacturer may submit a recall recommendation but ultimately, the FDA has the final say. The guidance attempts to clarify the difference between a recall and a product enhancement. A product enhancement is a change or improvement to a product which is not in violation and is part of a continuing improvement activity for that product. Examples may include changes that better meet the needs of the user, changes to the appearance that don’t impact it’s use or changes that facilitate the manufacture of the product. It is not a recall unless the change directly addresses a violation.
They use an example of a device that has a battery with a certain lifetime. If they introduce a battery with a longer life, this is an enhancement and not a recall. Contrasted, if the battery was supposed to have a 5 year life but some were not making it to the milestone, this would be a recall. Any device that fails to meet specifications or that does not perform as intended is considered adulterated. Changes to correct these issues are considered recalls. Devices that have inadequate instructions or incorrect labeling are treated as misbranded. Corrections to this labeling are considered a recall.
It is important to remember that a product enhancement may be reportable if it originated because of an effort to reduce the risk of harm. Additional labeling or changes to instructions may fall into this category. Simply said, if a change is made to bring a product in violation of the law into compliance then it is probably a recall.
To Be Clear?
A recall is a removal or correction of a product that is in violation of the law and hence the agency could take legal action. A recall is not a market withdrawal because a withdrawal involves something minor which would not elicit legal action from the FDA. A correction can include repair, modification or destruction of the product. A correction is not reportable if it is to improve performance or quality without reducing a risk associated with a violation. This is the area where a product enhancement may fall as well.
In any event, once the company files the necessary documentation, the FDA will review the issue, classification and strategy and then provide feedback as necessary. The distinctions can be nebulous so it is in the best interest of the company to engage the FDA to ensure that the correct actions are taken.
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