According to 21 CFR 807, what must manufacturers and initial distributors of medical devices do?

Manufacturers and initial distributors of medical devices are required to electronically register their establishments with the FDA, as outlined in 21 CFR 807. This registration process is essential for ensuring that the FDA has up-to-date information on the entities that produce and distribute medical devices. It helps the agency to maintain oversight of these businesses and to track the devices they manufacture.

This requirement for registration facilitates regulatory compliance and ensures that medical devices are manufactured and distributed according to the established safety and effectiveness standards. Having a registry also supports the FDA in monitoring the medical device market and identifying any potential safety issues.

The other choices involve important aspects of medical device regulation, but they do not represent the specific requirement outlined in 21 CFR 807. While reporting annual sales, conducting post-marketing surveillance, and filing pre-market notifications are related to the broader regulatory framework, they are not directly tied to the registration process mandated by this particular regulation.