If a company wants to destroy records of a second version of a non-implantable device, what is the correct action?

When considering the destruction of records related to a non-implantable device, it is crucial to recognize the regulatory requirements and the implications of record retention. For medical devices, including non-implantable types, certain records must be maintained for a specified period, even if the second version of the device does not have any current operational status.

The correct action is that no records can be destroyed. This is because manufacturers are typically required to retain records not just for the particular version that is currently marketed, but also for previous versions. This is important for accountability, tracking the history of the product, and compliance with regulatory mandates such as those from the FDA or other relevant authorities. These records might include manufacturing records, design records, and any clinical evaluation related to both versions of the device.

Maintaining comprehensive documentation helps ensure that a company can adequately respond to any future inquiries regarding the device, support quality control, and demonstrate compliance with the applicable industry standards and regulations. Hence, destroying any records related to the second version could pose significant legal and regulatory risks, making the retention of all records necessary.