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If your company does any defense work, ITAR registration is mandatory—regardless of customer flowdowns, order markings, or export activity. Being in the defense supply chain triggers the requirement. It’s not optional, and non-compliance can lead to serious penalties.

The "kitchen sink" approach to DFARS clause flowdown is now outdated for commercial contracts. As of November 17, 2023, prime contractors must only flow down clauses explicitly required by regulation or the contract. This change aims to reduce compliance risks, contract disputes, and administrative burdens. For non-commercial contracts, while the kitchen sink approach is still allowed, it is not recommended.

The US FDA is incorporating ISO 13485:2016 into its Quality Management System Regulation (QMSR) with a compliance deadline of February 2, 2026. This change aims to align US medical device regulations with international standards, emphasizing risk management, process validation, and regulatory compliance. Medical device manufacturers must prepare for this transition to ensure compliance and enhance global market access.