According to the FDA Compliance Policy Guide 555.425 what is the range of length (in mm) that is considered a hazard for the general public?

• A. 7-25 mm
• B. <7 mm
• C. 25-50 mm
• D. 5-7 mm

Answer: (A)

The key idea is how the FDA assigns hazard based on the size of a foreign object. According to FDA Compliance Policy Guide 555.425, objects within a mid-size range are flagged as hazardous for the general public because they are large enough to pose choking or tissue injury if ingested or handled, yet not so large that they would be obvious or easily detected before reaching the consumer. The specified range of 7–25 millimeters captures this balance, making those lengths the defined hazard window. Objects smaller than 7 mm are considered less likely to cause harm in typical exposures, while objects larger than 25 mm fall outside this particular hazard category and are assessed under different criteria. This is why the 7–25 mm range is the correct answer.