FDA approval

Hi Richard,

FDA response eua203041.ainc.memo.final.pdf

FDA submission, PEUA PCRmon Description

You should complete a full validation of the instrument with a SARS-CoV-2 assay .

FAQs on Testing for SARS-CoV-2 are available for your review and templates for IVD these EUA submissions are available on our website to help facilitate the preparation, submission, and authorization of an EUA:

• Molecular Diagnostic Template for Commercial Manufacturers (updated July 28, 2020)
• Home Specimen Collection Molecular Diagnostic Template (May 29, 2020)
• 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

• FAQs on Testing for SARS-CoV-2
  1. Test Settings
  2. Test Uses
• 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)
• In Vitro Diagnostics EUAs

… Coming from 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:

1. A detailed description of your device
2. The proposed Intended Use/Indications for Use
3. Protocols for any analytical, non-clinical, and clinical studies planned to evaluate your device but not yet started
4. Description and results of all analytical, non-clinical, and clinical data collected for this device to date
5. [Other information FDA would like to see – specific to this type of medical device product]
6. Specific questions you would like addressed.

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 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.