What is an FDA Initial Importer?
Under U.S. law, an Initial Importer is any importer who furthers the marketing of a device, drug, or food product from a foreign manufacturer to the person who makes the final delivery or sale of the product to the ultimate consumer or user.
This distinction matters because Initial Importers carry direct regulatory obligations to the FDA — separate from those of the foreign manufacturer. If you import FDA-regulated products into the United States and are the first U.S. entity to receive the shipment for further distribution, you are likely an Initial Importer.
Why the Initial Importer Role Matters
The FDA uses the Initial Importer as the U.S.-based responsible party when it needs to trace accountability for imported products. This means FDA can inspect your records, require adverse event reports from you, and hold you accountable for products that violate U.S. law — even if the product was manufactured entirely overseas.
Initial Importer Requirements for Medical Devices (21 CFR 807)
Medical device Initial Importers have the most comprehensive set of obligations under FDA regulations.
1. FDA Establishment Registration
All Initial Importers of medical devices must register their establishment with FDA annually using Form FDA 3673 through the FDA Unified Registration and Listing System (FURLS). Registration must be renewed each year between October 1 and December 31.
Your registration must include:
- Legal name and address of the U.S. establishment
- Name of the owner/operator
- All device types imported (by product code)
2. Device Listing
Initial Importers must maintain a current device listing for each device they import. This is done through the same FURLS system and must be updated when new devices are added or discontinued.
3. Recordkeeping Requirements
Under 21 CFR 821 and related regulations, Initial Importers must maintain distribution records sufficient to enable a MDR (Medical Device Report) investigation or recall. These records must include:
- Name and address of the device consignee
- Lot or batch number, or UDI where applicable
- Date of shipment or delivery
Records must be retained for a minimum of 2 years from the date of distribution.
4. Medical Device Reporting (MDR) — 21 CFR Part 803
This is one of the most critical obligations. Initial Importers must submit MDR reports to FDA when they receive or otherwise become aware that a device may have:
- Caused or contributed to a serious injury or death — report within 30 calendar days
- Malfunctioned in a way that could cause or contribute to death or serious injury if it recurred — report within 30 calendar days
Initial Importers must also:
- Establish written MDR procedures
- Maintain MDR event files for 2 years
- Submit annual baseline reports if required
5. Recalls and Corrections
When a device recall is initiated (either voluntarily or at FDA's request), the Initial Importer has obligations to:
- Notify consignees promptly
- Cooperate with FDA's recall strategy
- Submit required reports under 21 CFR Part 806 for corrections and removals
Initial Importer Requirements for Drugs and Biologics
For drug products, Initial Importers must:
- Register drug establishments and list drug products with FDA via the Drug Registration and Listing System (DRLS)
- Maintain records of distribution to facilitate recalls
- Submit Field Alert Reports (FARs) for certain product quality problems within 3 working days
- Cooperate with FDA inspections of their records
Initial Importer Requirements for Food Products (FSMA)
Under FSMA's Foreign Supplier Verification Program (FSVP), U.S. importers of food products must:
- Verify that the foreign supplier is producing food in a manner that meets U.S. safety standards
- Conduct supplier verification activities such as onsite audits, sampling and testing, or review of safety records
- Maintain records of all verification activities for at least 2 years
- Have a Qualified Individual (QI) responsible for conducting FSVP activities
FSVP applies to virtually all food importers, with some exemptions for certain very small importers and certain food categories.
Prior Notice Requirements
Separate from Initial Importer obligations, all importers of FDA-regulated food, drugs, and medical devices must comply with Prior Notice requirements under the Bioterrorism Act. Prior Notice must be submitted to FDA electronically before the shipment arrives at the U.S. port of entry.
Key details:
- For food: Prior Notice must be submitted no more than 15 days before arrival, and no less than 2 hours before arrival by road
- For medical devices and drugs: FDA has authority to detain shipments that arrive without proper documentation
Common Initial Importer Compliance Failures
- Failing to register the establishment or update the registration annually
- Not having written MDR procedures in place
- Inadequate distribution records — making traceability and recalls difficult
- Failure to report MDR events within required timeframes
- Not implementing a compliant FSVP program for food imports
What Happens if You Don't Comply?
Non-compliant Initial Importers face serious consequences:
- Import alerts — FDA can place your products on automatic detention, stopping all shipments
- Warning letters — publicly posted and requiring formal corrective action responses
- Consent decrees — court orders restricting your ability to import
- Civil and criminal penalties
How United Regulatory Can Help
We specialize in helping companies establish and manage their FDA Initial Importer programs — from establishment registration and MDR procedure development to FSVP program implementation and import alert resolution. Contact us for a free consultation to assess your current compliance posture.