Which of the following requirements does NOT apply to all Class I medical devices?

The correct answer is that the Design History File (DHF) requirement does not apply to all Class I medical devices. The DHF is a compilation of records that describes the design history of a finished device and is specifically intended for devices that are classified as Class II or Class III. For Class I devices, the requirements are less stringent, and while maintaining design controls can be beneficial, it is not mandated for all Class I devices.

Class I medical devices are subject to the general controls outlined in the Federal Food, Drug, and Cosmetic Act, which include proper labeling, manufacturing practices, and other requirements, but not necessarily a comprehensive DHF. Therefore, the obligation to maintain a DHF is not universally applicable to Class I devices.

In contrast, the Device Master File (DMF), Device History Record (DHR), and Medical Device Reporting (MDR) requirements are broader and must be adhered to for all Class I devices. DMF documents are often kept for regulatory purposes, DHR provides evidence that the device was manufactured according to specifications, and MDR mandates reporting of adverse events or device-related issues, all crucial for maintaining safety and compliance across the board for medical devices, including Class I.