South Korea says three Korean test-kit makers win
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Posted On: 03/28/2020 12:09:12 PM
South Korea says three Korean test-kit makers win U.S. FDA pre-approval
I wrote most of the below this past Thursday and sent it out in several PMs. It is appropriate to post in the public forum now.
The FDA has finally formalized its EUA policy due to overwhelming demand. There are three steps for methodology approval.
1. Pre-EUA, occurs when all of the FDA emergency requirements are met except for method data (live patients) and the actual building of the device. Pre-EUA is a major newsworthy event. DECN should meet these requirements as early as next week. When the requirements are met and submitted, the FDA reviews this abbreviated submission and issues in writing a Pre-UFA and then publishes such. New technologies and processes must go through the Pre-UEA step. Me too technologies and copies of copies of copies, what you see in recent company news releases, do not or have not.
2. EUA occurs, assuming no major changes to the product, when method data is submitted. The data submitted does not have to be live clinical data, only data from a lab test environment that is capable of realistically proving that a company's claims have been met by testing the work in progress. DECN's FDA counsel, and also one of my company's FDA counsel is also a Board member of MDMA, an organization that is shepherding 3-4 EUA applications at the present time. She told me Friday that EUA, while not a rubber stamp is a process receiving a maximum government pressure. That explains why all of the me too methods receiving EUA approval are little more than copies of each other, perhaps running on a different reading method (lab analyzer). Counsel also repeated what I have heard in many arenas -- she said she has never seen the FDA act in such a manner.
3. Method approval occurs after the full application for a 510K is filled out and is the least important part of the process, sometime down the road. At this point there may be millions of kits having been put in use.
I wrote most of the below this past Thursday and sent it out in several PMs. It is appropriate to post in the public forum now.
The FDA has finally formalized its EUA policy due to overwhelming demand. There are three steps for methodology approval.
1. Pre-EUA, occurs when all of the FDA emergency requirements are met except for method data (live patients) and the actual building of the device. Pre-EUA is a major newsworthy event. DECN should meet these requirements as early as next week. When the requirements are met and submitted, the FDA reviews this abbreviated submission and issues in writing a Pre-UFA and then publishes such. New technologies and processes must go through the Pre-UEA step. Me too technologies and copies of copies of copies, what you see in recent company news releases, do not or have not.
2. EUA occurs, assuming no major changes to the product, when method data is submitted. The data submitted does not have to be live clinical data, only data from a lab test environment that is capable of realistically proving that a company's claims have been met by testing the work in progress. DECN's FDA counsel, and also one of my company's FDA counsel is also a Board member of MDMA, an organization that is shepherding 3-4 EUA applications at the present time. She told me Friday that EUA, while not a rubber stamp is a process receiving a maximum government pressure. That explains why all of the me too methods receiving EUA approval are little more than copies of each other, perhaps running on a different reading method (lab analyzer). Counsel also repeated what I have heard in many arenas -- she said she has never seen the FDA act in such a manner.
3. Method approval occurs after the full application for a 510K is filled out and is the least important part of the process, sometime down the road. At this point there may be millions of kits having been put in use.
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