My rapid flow reply from FDA.......Of course I'm a pion but GOT SOMEONES ATTENTION!
Dear Mr. Rodriguez:
Your email of February 19, 2021 was forwarded to the Division of Industry and Consumer Education (DICE) at FDA's Center for Devices and Radiological Health (CDRH) DICE@fda.hhs.gov e-mail account.
To date, tests for SARS-CoV-2, the causative agent of Coronavirus Disease-2019 (COVID-19), receive Emergency Use Authorization (EUA) rather than premarket notification [510(k)] or premarket approval (PMA). EUAs) under review, including their existence, are confidential. Only the person designated as the point of contact (POC) on the EUA application may obtain information about the status of an EUA under review. If you are with Innova Medical Group, please have your Company’s POC on the EUA application call or email the lead reviewer listed on the acknowledgement letter for information. If the POC did not receive an acknowledgement, they can email COVID19DX@fda.hhs.gov. DICE cannot provide information about how may EUA reviews are in process or which tests those EUAs are for.
The turnaround time for EUA applications for in vitro diagnostic (IVD) tests for SARS-CoV-2, the causative agent of Coronavirus Disease 2019 (COVID-19), is answered in the answer to “Q: I submitted a pre-EUA or EUA request for a COVID-19 test. How long will the review take? (New 11/16/20)” in the “COVID-19 Test Development and Review: FAQs on Testing for SARS-CoV-2” section of “FAQs on Testing for SARS-CoV-2.” The FDA receives a high volume of EUA applications for SARS-CoV-2 tests. However, 180 days seems long, so your company’s POC on the EUA application may want to contact COVID19DX@fda.hhs.gov.
The FDA prioritizes EUA requests based on several factors that include, but are not limited to, the public health need of the product (such as point-of-care; high throughput), the extent to which the product would serve a significant unmet medical need, and the availability and adequacy of the information concerning the likelihood that the product is likely to be safe and effective in preventing, treating, or diagnosing the condition, as well as the availability of the product (the quantity and manufacturing capacity). More information about how the FDA reviews EUA applications is in:
Emergency Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other Stakeholders
https://www.fda.gov/regulatory-information/se...uthorities
The FDA strives to review Pre-EUA and EUA requests as quickly as possible. The time between receipt of an EUA application and granting or denying the EUA depends on many factors such as completeness of the application, complexity of the assay, etc. The FDA will communicate with each sponsor regarding its pre-EUA or EUA request as soon as possible. The review team will be in contact with the device manufacturer when their review is complete or if there are questions.
You may want to contact Innova Medical Group to see if they are willing to let you know what the status of their application is.
(I placed in bold BTW)
Please note that a great many SARS-CoV-2 tests were granted EUAs. They include molecular tests, antigen and serology tests. I believe some of the antigen tests are lateral flow tests. There are several tests that permit home specimen collection as well as one molecular prescription at-home test, one antigen prescription at-home test, and one over-the-counter (OTC) at-home antigen test.
The FDA cannot compel a manufacturer to market their product in the U.S., but you can send the manufacturer information about how to apply for an EUA. The EUA guidance is:
Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency: Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff
https://www.fda.gov/regulatory-information/se...-emergency
The manufacturer may also find the viral transport media guidance helpful:
Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Commercial Manufacturers, Clinical Laboratories and Food and Drug Administration Staff
https://www.fda.gov/regulatory-information/se...lic-health
The manufacturer may also find the frequently asked questions (FAQs) helpful:
FAQs on Testing for SARS-CoV-2
https://www.fda.gov/medical-devices/emergency...sars-cov-2
FAQs on Viral Transport Media During COVID-19
https://www.fda.gov/medical-devices/coronavir...g-covid-19
Links to the templates for manufacturers of SARS-CoV-2 tests to use to submit their EUA application data are on the “In Vitro Diagnostics EUAs” webpage at https://www.fda.gov/medical-devices/coronavir...stics-euas.
If you have general medical device questions, please email them to DICE@fda.hhs.gov. Additionally, please feel free to refer to DICE’s educational resources Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn) for comprehensive regulatory information about medical devices. For more information about the novel coronavirus and to keep apprised of developments, please see the FDA’s “Contacts for Medical Devices During the COVID-19 Pandemic,” “COVID-19 Educational Resources,” “Coronavirus Disease 2019 (COVID-19) Response ‘At-A-Glance’ Summary,” “Coronavirus Disease 2019 (COVID-19),” ”Frequently Asked Questions (FAQs) about Coronavirus Disease 2019 (COVID-19)” and “Innovation to Respond to COVID-19.”
Best regards,
Industry Team
Division of Industry and Consumer Education
Office of Communication and Education
Center for Devices and Radiological Health
U.S. Food and Drug Administration
This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed. This communication is intended for the exclusive use of the recipient(s) named in this correspondence. It may contain information that is protected, privileged, or confidential, and it should not be modified. It may not be disseminated, distributed, reproduced, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution, or copying is strictly prohibited. If you think you have received this communication in error, please immediately delete all copies from the saved sources and notify DICE by email at
ICE@fda.hhs.gov immediately.
Excellent customer service is important to us. Please take a moment to provide feedback regarding the customer service you have received:
https://www.research.net/r/cdrhcustomerservic...E=&S=E
Dear Mr. Rodriguez:
Your email of February 19, 2021 was forwarded to the Division of Industry and Consumer Education (DICE) at FDA's Center for Devices and Radiological Health (CDRH) DICE@fda.hhs.gov e-mail account.
To date, tests for SARS-CoV-2, the causative agent of Coronavirus Disease-2019 (COVID-19), receive Emergency Use Authorization (EUA) rather than premarket notification [510(k)] or premarket approval (PMA). EUAs) under review, including their existence, are confidential. Only the person designated as the point of contact (POC) on the EUA application may obtain information about the status of an EUA under review. If you are with Innova Medical Group, please have your Company’s POC on the EUA application call or email the lead reviewer listed on the acknowledgement letter for information. If the POC did not receive an acknowledgement, they can email COVID19DX@fda.hhs.gov. DICE cannot provide information about how may EUA reviews are in process or which tests those EUAs are for.
The turnaround time for EUA applications for in vitro diagnostic (IVD) tests for SARS-CoV-2, the causative agent of Coronavirus Disease 2019 (COVID-19), is answered in the answer to “Q: I submitted a pre-EUA or EUA request for a COVID-19 test. How long will the review take? (New 11/16/20)” in the “COVID-19 Test Development and Review: FAQs on Testing for SARS-CoV-2” section of “FAQs on Testing for SARS-CoV-2.” The FDA receives a high volume of EUA applications for SARS-CoV-2 tests. However, 180 days seems long, so your company’s POC on the EUA application may want to contact COVID19DX@fda.hhs.gov.
The FDA prioritizes EUA requests based on several factors that include, but are not limited to, the public health need of the product (such as point-of-care; high throughput), the extent to which the product would serve a significant unmet medical need, and the availability and adequacy of the information concerning the likelihood that the product is likely to be safe and effective in preventing, treating, or diagnosing the condition, as well as the availability of the product (the quantity and manufacturing capacity). More information about how the FDA reviews EUA applications is in:
Emergency Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other Stakeholders
https://www.fda.gov/regulatory-information/se...uthorities
The FDA strives to review Pre-EUA and EUA requests as quickly as possible. The time between receipt of an EUA application and granting or denying the EUA depends on many factors such as completeness of the application, complexity of the assay, etc. The FDA will communicate with each sponsor regarding its pre-EUA or EUA request as soon as possible. The review team will be in contact with the device manufacturer when their review is complete or if there are questions.
You may want to contact Innova Medical Group to see if they are willing to let you know what the status of their application is.
(I placed in bold BTW)
Please note that a great many SARS-CoV-2 tests were granted EUAs. They include molecular tests, antigen and serology tests. I believe some of the antigen tests are lateral flow tests. There are several tests that permit home specimen collection as well as one molecular prescription at-home test, one antigen prescription at-home test, and one over-the-counter (OTC) at-home antigen test.
The FDA cannot compel a manufacturer to market their product in the U.S., but you can send the manufacturer information about how to apply for an EUA. The EUA guidance is:
Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency: Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff
https://www.fda.gov/regulatory-information/se...-emergency
The manufacturer may also find the viral transport media guidance helpful:
Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Commercial Manufacturers, Clinical Laboratories and Food and Drug Administration Staff
https://www.fda.gov/regulatory-information/se...lic-health
The manufacturer may also find the frequently asked questions (FAQs) helpful:
FAQs on Testing for SARS-CoV-2
https://www.fda.gov/medical-devices/emergency...sars-cov-2
FAQs on Viral Transport Media During COVID-19
https://www.fda.gov/medical-devices/coronavir...g-covid-19
Links to the templates for manufacturers of SARS-CoV-2 tests to use to submit their EUA application data are on the “In Vitro Diagnostics EUAs” webpage at https://www.fda.gov/medical-devices/coronavir...stics-euas.
If you have general medical device questions, please email them to DICE@fda.hhs.gov. Additionally, please feel free to refer to DICE’s educational resources Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn) for comprehensive regulatory information about medical devices. For more information about the novel coronavirus and to keep apprised of developments, please see the FDA’s “Contacts for Medical Devices During the COVID-19 Pandemic,” “COVID-19 Educational Resources,” “Coronavirus Disease 2019 (COVID-19) Response ‘At-A-Glance’ Summary,” “Coronavirus Disease 2019 (COVID-19),” ”Frequently Asked Questions (FAQs) about Coronavirus Disease 2019 (COVID-19)” and “Innovation to Respond to COVID-19.”
Best regards,
Industry Team
Division of Industry and Consumer Education
Office of Communication and Education
Center for Devices and Radiological Health
U.S. Food and Drug Administration
This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed. This communication is intended for the exclusive use of the recipient(s) named in this correspondence. It may contain information that is protected, privileged, or confidential, and it should not be modified. It may not be disseminated, distributed, reproduced, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution, or copying is strictly prohibited. If you think you have received this communication in error, please immediately delete all copies from the saved sources and notify DICE by email at
ICE@fda.hhs.gov immediately. Excellent customer service is important to us. Please take a moment to provide feedback regarding the customer service you have received:
https://www.research.net/r/cdrhcustomerservic...E=&S=E
