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Next revision 		Previous revision
bdev:fda [2020/11/25 15:11]
richard created 		bdev:fda [2021/08/16 22:22] (current)
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 ====== FDA approval ====== ====== 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 .
 +
 +[[https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-testing-sars-cov-2|FAQs on Testing for SARS-CoV-2]] are available for your review and templates for IVD these EUA submissions are available on our [[https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas|website]] to help facilitate the preparation, submission, and authorization of an EUA:
 +
 +
 +  * [[https://docs.google.com/document/d/1-iPm6V_cFiCuNQQChnDlopDxaq-5e7aR89YfFiaGPuY/edit|Molecular Diagnostic Template for Commercial Manufacturers (updated July 28, 2020)]]
 +  * [[https://docs.google.com/document/d/17SdRYwKclNT0GFq6arKNdGY3Zjb7hsPxFDppcSkihjM/edit#|Home Specimen Collection Molecular Diagnostic Template (May 29, 2020)]]
 +  * [[https://docs.google.com/document/d/1YX_8R-JDn_z5Afvxp_ENbyzdPVZr3emfWkYugpr1Xm8/edit|Template for Manufacturers of Molecular and Antigen Diagnostic COVID-19 Tests for Non-Laboratory Use (July 29, 2020)]]
 +
 +
 + 
 +Respectfully,
 +Yvonne
 +COVID19DX IVD Team
 +CDRH
 +U.S. Food and Drug Administration
 +10903 New Hampshire Avenue
 +Silver Spring, MD  20993
 +COVID19DX@fda.hhs.gov
 +
  
   * [[https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-testing-sars-cov-2|FAQs on Testing for SARS-CoV-2]]   * [[https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-testing-sars-cov-2|FAQs on Testing for SARS-CoV-2]]
 +    - [[https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-test-settings-faqs-testing-sars-cov-2|Test Settings]]
 +    - [[https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-test-uses-faqs-testing-sars-cov-2|Test Uses]]
   * [[https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-coronavirus-disease-2019-tests-during-public-health-emergency-revised|Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff: Policy for Coronavirus Disease-2019 Tests during the Public Health Emergency (Revised)]]   * [[https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-coronavirus-disease-2019-tests-during-public-health-emergency-revised|Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff: Policy for Coronavirus Disease-2019 Tests during the Public Health Emergency (Revised)]]
 +  * [[https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas|In Vitro Diagnostics EUAs]]
 +
 +
 +
 +----
 +
 +
 +... Coming from [[https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-test-settings-faqs-testing-sars-cov-2|Test Settings]]
 +
 + As discussed in the EUA template, an EUA request for a POC test should include data to demonstrate that non-laboratory personnel can perform the test accurately in the intended use environment, as well as data to demonstrate the robustness of the device for near-patient testing, i.e., that the device is not sensitive to environmental and usage variation.
 +
 +
 +
 +----
 +
 +
 +Please submit a PEUA using the template   A Pre-EUA submission is made by a sponsor in situations in which the sponsor still has outstanding questions (e.g., questions about their validation studies).
 +
 +
 +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.
 +
 +
 +----
 +      
 +[[https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/how-submit-pre-eua-vitro-diagnostics-fda|How to Submit a Pre-EUA for In vitro Diagnostics to FDA]]
 +
 +
 +**Are you interested in submitting a Pre-EUA for an IVD test for a pathogen with a current EUA declaration?
 +**
 +
 +  * 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.).
 +  * 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.
 +
 +
 +
 +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.
 +
 +        
 +
 +
  
  
  
bdev/fda.1606317116.txt.gz · Last modified: 2021/08/16 22:21 (external edit)

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