FDA Recall Regulations

OMB 0910-0249

OMB 0910-0249

This information collection supports FDA regulations governing recalls. The information collection provisions apply to all regulated products (i.e., food, including animal feed; drugs, including animal drugs; medical devices, including in vitro diagnostic products; cosmetics; biological products intended for human use; and tobacco). Respondents to the collection are those who introduce FDA-regulated products into interstate commerce or who are otherwise subject to the applicable regulations.

The latest form for FDA Recall Regulations expires 2021-04-30 and can be found here.

OMB Details

Firm Initiated Recall and Recall Communications

Federal Enterprise Architecture: Health - Public Health Monitoring


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