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Attachment J.1 Data Reporting RequirementsTesting data enumerated in sections A through C below shall be reported daily to the HHS Protect system or other system designated by the Government. Test
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01
Obtain a copy of the guidance document titled 'Guidance for Industry and FDA Staff - In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions.'
02
Review the instructions provided in the guidance document on how to fill out the necessary sections and forms.
03
Gather all relevant information and data required for the completion of the guidance document.
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Follow the specific guidelines and recommendations outlined in the document for accurately filling out the necessary sections.
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Submit the completed guidance document according to the instructions provided in the document.

Who needs guidance-for-industry-and-fda-staff--in-vitro-diagnostic-ivd?

01
Manufacturers of in vitro diagnostic (IVD) devices seeking guidance on conducting studies and completing necessary documentation.
02
FDA staff members responsible for reviewing and evaluating submissions related to IVD devices.

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It is a document that provides guidance for industry and FDA staff regarding in vitro diagnostic devices.
Manufacturers and developers of in vitro diagnostic devices are required to file this guidance.
The guidance can be filled out online through the FDA website or submitted in hard copy via mail.
The purpose of the guidance is to ensure compliance with FDA regulations and to provide clear instructions on the submission process.
Information such as device description, intended use, validation data, and labeling must be reported.
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