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FDA Predetermined Change Control Plans for AI Devices
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Export-control rules regulate specified chips, software, technology, equipment and activities according to jurisdiction, destination, end user and technical thresholds.
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The 2022 U.S. BIS rules and Dutch equipment controls are distinct measures.
The U.S. Bureau of Industry and Security issued October 2022 controls on certain advanced-computing chips and semiconductor-manufacturing items under the Export Administration Regulations. NVIDIA disclosed in an August 2022 SEC filing that the U.S. government had imposed an immediate license requirement for exports to China and Russia of its A100 and forthcoming H100 chips. Dutch export controls on certain lithography equipment are separate national measures. Rules changed over time, so historical examples should be dated and checked against current regulations.
A U.S. exporter can consult the EAR and BIS rules to determine whether an item or transaction requires authorization.
NVIDIA’s August 2022 SEC filing names A100 and forthcoming H100 chips in a then-new license requirement for certain destinations.
The October 2022 BIS rule also addressed specified semiconductor-manufacturing equipment; this is distinct from Dutch measures on lithography equipment.
An ECCN helps classify an item under the EAR, but classification alone does not determine every license requirement; destination, end use and parties matter.
Check current BIS regulations and applicable foreign controls for the exact item, transaction date, destination and end user. Distinguish U.S. rules from Dutch/EU controls and historical thresholds from current rules. Do not infer present authorization status from a chip model name alone.
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Export-control rules regulate specified chips, software, technology, equipment and activities according to jurisdiction, destination, end user and technical thresholds. The 2022 U.S. BIS rules and Dutch equipment controls are distinct measures.
Ticaret Departmanının bir parçası olan Sanayi ve Güvenlik Bürosu (BIS), bu ihracat kontrol kurallarını yayınlar ve uygular.
The H100 was a prominent example under the initial U.S. advanced-computing controls; later rules changed technical parameters and coverage.
NVIDIA’s product pages report 400 GB/s NVLink bandwidth for the A800 40GB Active and 900 GB/s for H100. This is a specification comparison, not a claim about why the product was designed.
The October 2022 BIS rule covered specified semiconductor-manufacturing equipment as well as certain advanced-computing chips. Dutch lithography controls are separate national measures.
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FDA Predetermined Change Control Plans for AI Devices
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