Regulatory Watch
FDA draft guidance to strengthen voluntary recalls
In a new draft guidance, “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” there are recommendations in three key areas: training, recordkeeping and procedures.
Proper training is an important element to effectively executing a recall. The draft guidance advises companies on ways to best identify and train appropriate personnel on their responsibilities during a recall, establish a recall communications plan, and identify what FDA reporting requirements there may be, among other things.
Thorough and organized recordkeeping is especially important as the agency continues its efforts to improve recalls through product traceability by tapping into modern approaches such as blockchain technology.
Written recall initiation procedures help minimize delays created by uncertainty. Using initiation procedures can help reduce the amount of time a defective or potentially harmful product is on the market, and that in turn reduces consumers’ potential exposure. For consignees of a company that initiates a recall, these procedures can help extend the recall quickly throughout the distribution chain. The agency has also adopted new policies for moving forward with rapidly posting new recalls to the FDA’s Enforcement Report, which is a web listing of all recalls monitored by the FDA.
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