Registration

How to Submit a 510K

How to Submit a 510K

Three types of Premarket Notifications can be submitted to the Food and Drug Administration (FDA) Traditional, abbreviated, and special 510Ks. The traditional 510K program is utilized to seek marketing authorization for any device. When submitting a 510K there is not a form to submit however submission requirements can be found under 21 CFR part 807.

EUDAMED Registration

EUDAMED Registration

The EUDAMED Actors module is all set to start accepting registrations from member states and economic operators from...

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