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--- bdev:fda [2020/11/25 17:49]
richard
+++ bdev:fda [2021/08/16 22:22] (current)
@@ Line 1: / Line 1: @@
 ====== FDA approval ======
 Hi Richard,
+FDA response {{ :bdev:eua203041.ainc.memo.final.pdf |}}
+FDA submission, [[https://docs.google.com/document/d/1OXDPJaVru2Kt8dVt_uFsm47i1tnC-enXKWafNjTsnwM/edit#heading=h.20fzukxeaohe|PEUA PCRmon Description]]
 You should complete a full validation of the instrument with a SARS-CoV-2 assay .
@@ Line 68: / Line 76: @@
   * Email CDRH-EUA-Templates@fda.hhs.gov and request a copy of the most recent EUA review template relevant to your test.
-  *   * Please include a brief description of your IVD (target pathogen, device technology – assay based on molecular, antigen or antibody detection, etc.).
+    * Please include a brief description of your IVD (target pathogen, device technology – assay based on molecular, antigen or antibody detection, etc.).
   * After you receive the EUA review template, populate the draft template with the information and data that you currently have for your IVD test.
   * 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.
+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]]
+----
+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.
+In your PEUA package, the template (MS word document) outlining the following information about your specific device; including:
+  * 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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