AI-Enabled Medical Device Risk Classification Tool - For Beta Testing

For GMDs only: Get an estimated risk classification for your general medical devices.

⚠️ IMPORTANT DISCLAIMER:

This AI-Enabled Medical Device Risk Classification Tool (the "Tool") is currently in beta testing and provides estimated classifications of medical devices for guidance purposes only. These estimates are not official HSA determinations and should not be relied upon for regulatory submissions or compliance decisions. Official medical device classifications must be obtained through HSA's formal regulatory processes. HSA shall not be liable to any user of the Tool for decisions made based on the Tool's outputs.

Disclaimers

Classification Accuracy: The Tool provides estimated risk classifications that may differ from official HSA determinations. HSA does not guarantee the classification accuracy of the Tool and any discrepancies shall not constitute grounds for challenging HSA regulatory decisions. Users of the Tool are solely responsible for independently verifying the accuracy and suitability of all outputs for their specific purposes, including but not reserved to, in accordance with existing legal, regulatory and other requirements for the time being in force (e.g. GN-13, GL-07, etc.).

No Warranties: The Tool is provided "as is" and HSA does not provide any warranty or representation with regard to the use and outputs of the Tool, in particular, all warranties and conditions whether express or implied by applicable law, including the merchantability or fitness for any specific purpose, are hereby excluded.

No Regulatory Advice: The Tool and any derived outputs do not provide or form any regulatory advice or replace consultation with HSA. Users of the Tool should always seek official guidance from HSA for accurate classifications, specific regulatory requirements and compliance obligations.

Limitation of Liability: To the fullest extent allowed by applicable law, HSA shall under no circumstances be liable to any user of the Tool in contract, tort or otherwise for any and all direct, indirect, consequential, special or incidental losses or damages, and/or any loss of profit, loss of revenue, loss of business opportunity, loss of goodwill or any other form of economic loss incurred by the user of the Tool, and/or any consequences arising from the use of the Tool, including but not limited to regulatory delays, compliance issues, or commercial decisions based on the Tool’s outputs.

Beta Status Warning: The Tool is in the beta testing phase and subject to ongoing development and refinement. Features, accuracy, and availability may change without notice to any user. HSA shall not be liable to any user of the Tool for any reliance placed on previous class estimations if there are subsequent changes, updates, or modifications to the Tool's functionality or outputs.