Final answer:
The initial importer of a medical device is required to report incidents where the device may have contributed to a death or serious injury and is under the oversight of the CDRH. They must follow FDA regulations for postmarketing risk management and are responsible for continual monitoring of the device's safety and effectiveness.
Step-by-step explanation:
The initial importer of a medical device MUST report incidents in which a device may have caused or contributed to a death or serious injury. This responsibility falls under the regulatory oversight of the Center for Devices and Radiological Health (CDRH), which is a branch of the FDA that is in charge of the premarket approval, as well as the postmarket surveillance, of medical devices. Reporting such incidents is crucial for pharmacovigilance and ensures that the safety and effectiveness of medical devices are monitored continually.
The requirements for postmarketing risk management can also include the reporting of device malfunctions, but this is generally done through mandatory reporting systems rather than in an annual report. Additionally, these requirements may include conducting additional clinical trials or studies as part of Phase IV trials or other safety surveillance activities, as mandated by the FDA.
Therefore, while maintaining quality assurance files and sharing responsibility for submittals with other distributors are good practices, they are not the direct legal obligation of an initial importer as defined in the key question. The government, through agencies like the FDA, also has a role in ensuring that medical equipment and protocols are fail-safe, which includes developing and enforcing protocols for the cleaning or sterilizing of medical equipment.