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Application 1390 Cutaneous patch testing for investigation of allergic dermatitis Revision of MBS items (1201212021). Thank you for taking the time to complete this feedback form on the draft protocol
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Application 1390- epicutaneous patch is a form for submitting information about an epicutaneous patch medical device for regulatory approval.
Manufacturers or distributors of epicutaneous patch medical devices are required to file application 1390- epicutaneous patch.
Application 1390- epicutaneous patch must be completed with detailed information about the epicutaneous patch device, its intended use, manufacturing process, and safety data.
The purpose of application 1390- epicutaneous patch is to apply for regulatory approval to market an epicutaneous patch medical device.
Information such as device design, materials used, intended use, labeling, risk assessment, and clinical data must be reported on application 1390- epicutaneous patch.
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