Electronic Submission of Medical Device Registration and Listing

OMB 0910-0625

OMB 0910-0625

This information collection request covers the reporting and recordkeeping provisions associated with FDA's implementation of sections 222, 223, and 224 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which require that device establishment registrations and listings under section 21 U.S.C. 360(p) (including the submission of updated information) be submitted to the Secretary by electronic means, unless the Secretary grants a request for waiver of the requirement because the use of electronic means is not reasonable for the person requesting the waiver.

The latest form for Electronic Submission of Medical Device Registration and Listing expires 2022-06-30 and can be found here.

OMB Details

Annual Registration

Federal Enterprise Architecture: Health - Consumer Health and Safety

Form FDA 3673FDA 3673Fillable Fileable SignableForm

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.


© 2021 OMB.report | Privacy Policy