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bdev:fda

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bdev:fda [2020/11/25 17:50]
richard 		bdev:fda [2021/08/16 22:22] (current)
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 ====== FDA approval ====== ====== FDA approval ======
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 Hi Richard, Hi Richard,
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 +FDA response {{ :bdev:eua203041.ainc.memo.final.pdf |}}
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 +FDA submission, [[https://docs.google.com/document/d/1OXDPJaVru2Kt8dVt_uFsm47i1tnC-enXKWafNjTsnwM/edit#heading=h.20fzukxeaohe|PEUA PCRmon Description]]
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 You should complete a full validation of the instrument with a SARS-CoV-2 assay . You should complete a full validation of the instrument with a SARS-CoV-2 assay .
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   * Send the draft template back to FDA for review as a Pre-EUA submission using the instructions that are provided along with the EUA review template (which includes sending 1 hard copy and 1 electronic copy to the Document Control Center).     * Send the draft template back to FDA for review as a Pre-EUA submission using the instructions that are provided along with the EUA review template (which includes sending 1 hard copy and 1 electronic copy to the Document Control Center).  
       * The Pre-EUA review is a very interactive process. The draft review template is a shared “work-in-progress” document which you will populate with information and data about your test. FDA will review and provide feedback to you.       * The Pre-EUA review is a very interactive process. The draft review template is a shared “work-in-progress” document which you will populate with information and data about your test. FDA will review and provide feedback to you.
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 +Here is the partially filled template [[https://docs.google.com/document/d/1FesJTg4_F5URoEy7ZrEI_voXRWozk4HbUEAplhy1IXY/edit#|Template for Manufacturers of Molecular and Antigen Diagnostic COVID-19 Tests for Non-Laboratory Use]]
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 +----
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 +If this is for over the counter, this is the correct template Template for Manufacturers of Molecular and Antigen Diagnostic COVID-19 Tests for Non-Laboratory Use (July 29, 2020), however within this template it refers to the other templates for specific studies.  The document you provided is incomplete and cannot be accepted a PEUA.
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 +In your PEUA package, the template (MS word document) outlining the following information about your specific device; including:
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 +  * A detailed description of your device
 +  * The proposed Intended Use/Indications for Use
 +  * Protocols for any analytical, non-clinical, and clinical studies planned to evaluate your device but not yet started
 +  * Description and results of all analytical, non-clinical, and clinical data collected for this device to date.
 +  * [Other information FDA would like to see – specific to this type of medical device product]
 +  * Specific questions you would like addressed.
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bdev/fda.1606326641.txt.gz · Last modified: 2021/08/16 22:21 (external edit)

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