Export Requirements for Products Not Approved for Sale in the United States
This guidance summarizes and explains the requirements and procedures under the FDA Export Reform and Enhancement Act of 1996 for exporting human drugs, animal drugs, biological products, devices, food, food additives, color additives, and dietary supplements that may not be sold or distributed in the United States.
What You Need to Know? 👇
What are the basic requirements for exporting medical devices under Section 801(e)(1) of the FDA Export Reform and Enhancement Act?
Medical devices must meet four criteria: accord to foreign purchaser specifications, not conflict with importing country laws, be labeled for export on shipping packages, and not be sold domestically in the US.
Can unapproved medical devices be exported to countries not listed in Section 802(b)(1)(A)?
Yes, but with restrictions. Devices may be exported under Section 801(e)(2) requiring FDA determination of safety and foreign country approval, or under Section 802(e) for tropical diseases with prior FDA application approval.
What documentation is required to demonstrate compliance with foreign country laws for device exports?
Either a letter from the foreign government agency confirming marketing approval or legal compliance, or a notarized certification by a US company official acknowledging Title 18 Section 1001 penalties for false statements.
Are there different export requirements for investigational medical devices versus commercial devices?
Yes. Investigational devices for listed countries can be exported under Section 802(c) without prior FDA approval, while commercial devices may require marketing authorization in listed countries or additional FDA determinations.
What recordkeeping obligations apply to medical device exports under the FDA Export Reform Act?
Exporters must maintain records showing foreign purchaser specifications, compliance with foreign laws, export labeling, domestic non-sale status, plus specific product details, consignee information, export dates, and quantities per 21 CFR 1.101.
How does the “substantial conformity” requirement with cGMP apply to exported medical devices?
Devices exported under Section 802 must be manufactured in “substantial conformity” with current Good Manufacturing Practices, meaning firms should have passed recent GMP inspections with violations corrected and credible prevention systems established.
What You Need to Do 👇
Recommended Actions
- Determine appropriate export pathway based on product type and destination country
- Verify compliance with basic export requirements:
- Foreign purchaser specifications
- Compliance with importing country laws
- Proper labeling for export
- No US sales/distribution
- Implement recordkeeping system to document:
- Product specifications
- Export compliance
- Shipping records
- Foreign approvals/authorizations
- Establish process for FDA notifications when required
- Ensure manufacturing compliance with cGMPs
- Develop labeling that meets both US and foreign requirements
- Create procedures for maintaining export documentation
- Train relevant personnel on export requirements and procedures
- Conduct periodic audits of export compliance program
- Monitor changes to export regulations and update procedures as needed
Key Considerations
Labelling
- Must be labeled on the outside of the shipping package that it is intended for export
- Must be labeled in accordance with the requirements and conditions of use in the listed country
- Must be labeled in the language and units of measurement used in or designated by the country to which the product would be exported
- For drugs with unapproved uses, labeling must state that those uses are not approved under the Act
Safety
- Must not expose patients to unreasonable risk of illness or injury
- Must have probable benefit that outweighs risks
- Must not be adulterated or contain filthy, putrid or decomposed substances
- Must be manufactured in substantial conformity with cGMPs
Other considerations
- Must comply with laws of importing country
- Must meet foreign purchaser’s specifications
- Must not be sold or offered for sale in US
- Must maintain records of all exported products and countries
- Must provide notification to FDA when exporting under certain provisions
- Special provisions exist for:
- Investigational use exports
- Exports in anticipation of foreign approval
- Exports for tropical diseases
- Partially processed biological products
Relevant Guidances đź”—
- Design Controls for Medical Device Manufacturers
- Quality System Information Requirements for Premarket Submissions
- Current Good Manufacturing Practice Requirements for Combination Products
- Compliance Policy for Combination Product Postmarketing Safety Reporting Requirements
Related references and norms đź“‚
- 21 CFR Part 210/211: Current Good Manufacturing Practice for Drugs
- 21 CFR Part 820: Quality System Regulation for Medical Devices
- 21 CFR Part 606: Current Good Manufacturing Practice for Blood and Blood Components
- 21 CFR Part 812: Investigational Device Exemption
- 21 CFR Part 312: Investigational New Drug Application