Templates & Checklists.
Free FDA compliance checklists and templates. Generate and download many of them instantly; others we email to you — all to support your FDA compliance efforts.
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FDA Registration Checklist
A comprehensive checklist for FDA facility registration (food, drug, device). Covers all documents needed, timeline, and common pitfalls.
What you'll learn
- Complete document requirements for food, drug, and device facility registration
- Step-by-step timeline from DUNS number acquisition to FDA confirmation
- Common pitfalls that cause registration delays or rejections
- Renewal deadlines and annual re-registration requirements
What's inside
MoCRA Compliance Workbook
Step-by-step MoCRA compliance workbook for cosmetics companies. Facility registration, product listing, adverse event reporting templates.
What you'll learn
- How to register cosmetic facilities and list products under MoCRA
- Adverse event reporting requirements and documentation templates
- Safety substantiation record-keeping best practices
- Key MoCRA deadlines and enforcement timelines for 2026
What's inside
US Agent Requirements Guide
Everything foreign facilities need to know about designating a US Agent. Requirements by product type, costs, and responsibilities.
What you'll learn
- US Agent requirements for food, drug, device, and cosmetics facilities
- How to evaluate and select a qualified US Agent provider
- Typical costs and pricing structures across the industry
- Legal responsibilities and communication obligations of a US Agent
What's inside
Related Resources
Most Popular
The most downloaded compliance resources by our users.
FDA Food Facility Registration Checklist
Step-by-step checklist for completing FDA food facility registration
FSVP Importer Compliance Checklist
Comprehensive checklist covering all FSVP requirements for food importers
Medical Device Listing Checklist
Checklist for device establishment registration and listing, including product codes and UDI/GUDID readiness
MoCRA Product Listing Template
Data-capture template for cosmetic product listing under MoCRA, including responsible person and ingredient statement
FDA Inspection Preparation Checklist
Comprehensive checklist to prepare for FDA facility inspections
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Browse our complete library of free compliance resources.
FDA Food Facility Registration Checklist
ChecklistStep-by-step checklist for completing FDA food facility registration
FSVP Importer Compliance Checklist
ChecklistComprehensive checklist covering all FSVP requirements for food importers
Medical Device Listing Checklist
ChecklistChecklist for device establishment registration and listing, including product codes and UDI/GUDID readiness
Dietary Supplement Label Review Template
TemplateTemplate for reviewing supplement labels against FDA requirements
Drug Establishment Registration Checklist
ChecklistChecklist for domestic and foreign drug establishment registration
MoCRA Product Listing Template
TemplateData-capture template for cosmetic product listing under MoCRA, including responsible person and ingredient statement
Adverse Event Reporting Log Template
TemplateTemplate for tracking and documenting adverse event reports
FDA Inspection Preparation Checklist
ChecklistComprehensive checklist to prepare for FDA facility inspections
US Agent Responsibilities Reference
GuideReference on US Agent requirements and responsibilities for foreign establishments
Prior Notice Filing SOP
ReferenceStandard operating procedure for Prior Notice filing, including timing rules by transport mode
NDC Number Assignment Template
TemplateTemplate for organizing and tracking NDC number assignments
FDA Registration Renewal Calendar
TemplateAnnual calendar template for tracking FDA registration renewals
Supplier Qualification Checklist
ChecklistChecklist for qualifying and evaluating foreign suppliers
cGMP Self-Assessment (21 CFR 210/211)
TemplateSelf-assessment questionnaire mapped to 21 CFR 210/211 for drug cGMP readiness
Product Recall Response Plan Template
TemplateTemplate for developing a product recall response procedure
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