International Traffic in Arms Regulations compliance
Healthcare and life sciences companies exporting medical devices, diagnostic equipment, or dual-use biological technologies face a sharper compliance burden under the International Traffic in Arms Regulations than most legal teams anticipate. The U.S. Department of State Directorate of Defense Trade Controls administers ITAR, but the U.S. Department of Commerce Bureau of Industry and Security frequently intersects on jurisdiction determinations when a product crosses the EAR-ITAR boundary. Misclassification between these two regimes is the leading source of voluntary disclosures from life sciences exporters, and compliance teams are actively auditing product classification files and foreign national access controls before those disclosures become necessary.
Watch
- DDTC's Category XV(f) coverage: does your telemetry hardware qualify as a defense article?
- Foreign national access controls inside domestic R&D and manufacturing facilities
- BIS 600-series EAR controls as an off-ramp from ITAR jurisdiction for certain medical devices
- Voluntary self-disclosure procedures at DDTC following the 2023 penalty settlement pattern
Recent material activity in Healthcare & Life Sciences
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FDA issues Complete Response Letter for novel GLP-1 receptor agonist oral formulation
The FDA issued a CRL for a once-daily oral GLP-1 receptor agonist citing manufacturing consistency concerns at the primary production facility. The agency requested additional CMC data and a pre-approval inspection befor…
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