I yield to that. Vac-check does not use a sampl
Post# of 22467
(Total Views: 333)
Posted On: 09/08/2022 9:11:20 PM
I yield to that.
I was scratching my head trying to determine what FDA category vac-check would fall under.
The closes item I could find was this:
https://www.fda.gov/science-research/licensin...feit-pharm
That why I phase it
" It should fall somewhere under "Overview of IVD Regulation" "
Because as far as I know the Drug Supply Chain Security Act (DSCSA) is a fairly new public law for the FDA and the vac-check diagnostic test is an in vitro test, so in my opinion the "IVD Regulation" will be modified to fit this new categogy. Drug Supply Chain Security Act (DSCSA)
The Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54) amended the18 Federal Food, Drug, and Cosmetic Act (FD&C Act) to establish requirements for product19
tracing, verification, and product identification for certain drug products that are distributed in20
the United States.
June 2021 Draft
https://www.fda.gov/media/111468/download
Quote:
Vac-check does not use a sample taken from the body, it takes it from the vaccine vial and the remaining vaccine spiked with QDs then goes into the body.
I was scratching my head trying to determine what FDA category vac-check would fall under.
The closes item I could find was this:
Quote:
A Hand Held Portable Device Based on LEDS for Use in The Detection of Counterfeit Pharmaceutical Drugs and Packaging
https://www.fda.gov/science-research/licensin...feit-pharm
That why I phase it
" It should fall somewhere under "Overview of IVD Regulation" "
Because as far as I know the Drug Supply Chain Security Act (DSCSA) is a fairly new public law for the FDA and the vac-check diagnostic test is an in vitro test, so in my opinion the "IVD Regulation" will be modified to fit this new categogy. Drug Supply Chain Security Act (DSCSA)
The Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54) amended the18 Federal Food, Drug, and Cosmetic Act (FD&C Act) to establish requirements for product19
tracing, verification, and product identification for certain drug products that are distributed in20
the United States.
June 2021 Draft
https://www.fda.gov/media/111468/download
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