What is the duration for which impact resistance records are required to be kept by the FDA?

The requirement to keep impact resistance records for a duration of three years aligns with the FDA's regulations on the retention of records related to certain aspects of product quality and safety. This timeframe allows for adequate documentation and tracking of the performance and safety attributes of products, especially those that may pose risks to consumers.

Maintaining these records for three years ensures that sufficient data is available for potential audits, investigations, or safety evaluations that may arise. It reflects the FDA's focus on ensuring that manufacturers are held accountable for the impact resistance of their products throughout a significant duration of the product lifecycle, while balancing the need for practical record-keeping for both the manufacturers and regulatory bodies.

The other durations listed do not conform to the FDA guidelines for this specific type of record retention. Keeping records for shorter durations may not provide enough oversight to ensure that ongoing compliance is met, while longer durations could result in unnecessary burdens and storage issues for manufacturers.