Food & Drug Safety
Support FDA facility registration, drug/device submission pathways, import safety screening, and recall coordination for regulated food, drug, device, and cosmetic products.
Food and Drug Administration (HHS) · Health and Human Services
89%
Review on-time
3
Programs
5
Journeys / flow steps
Enter this domain
Three roles. One product surface. Citizen applies, staff adjudicates, admin configures.
Programs
FFR
Active food facility registration number
~7d · status
NDA/510(k)
Filing decision and eventual approval/clearance/CR letter tracking
~180d · license
Import Safety
May proceed, detention, refusal, or reconditioning order
~5d · status
AI capabilities
- Submission completeness checks
- Adverse event triage
- Facility risk scoring
Citizen flow
- Identify regulated product path
- Prepare submission package
- Respond to information requests
- Track decision status
Operator flow
- Triage safety signals
- Review facility inspections
- Coordinate recalls
Primary statutes
- 21 USC § 393 — FDA mission
- 21 USC § 360 — Registration of producers of drugs/devices
- 21 USC § 355 — New drug applications
- 21 USC § 360c — Device classification
- 21 USC § 350d — Food facility registration (Bioterrorism Act / FSMA)
- 21 USC § 381 — Imports and exports
Why this domain is unique
Product classification (drug vs device vs food), 510(k)/NDA pathways, facility registration under FDCA, and import alert holds are product-safety regimes—not citizen benefit FPL rules.