This Article Deals about FDA Registration for Diagnostic Kits. The approved SARS-CoV-2 molecular diagnostics was published on February 21, 2023 by the Food and Drug Administration, USA. These EUAs have been granted with specific authorization requirements for the manufacturer and accredited labs for each separate test in FDA Registration. Test attributes are listed in the “Attributes” column. For example, tests authorized for the screening of asymptomatic individuals without known exposure are listed with “screening” in the attribute column; pooling, multi-analyte, saliva, home collection, and home testing are similarly listed. Tests available without a prescription include the attribute “DTC” (for direct-to-consumer home collection tests) or “OTC” (for over-the-counter at-home tests). Tests that are offered over-the-counter or direct-to-consumer contain these designations (for over-the-counter at-home tests). To view further authorization records, such as letters approving EUA modifications or updates and a list of other brand names approved under a particular EUA
The following tests have “Single Target” in their attribute column:
- Created to identify a single viral target on the SARS-CoV-2 genome
- They are more prone to miss detecting novel variations because of changes in performance brought on by viral mutations.
The tests shown in the attribute column with “Many Targets” are:
- Created to identify at least two viral targets or regions of the SARS-CoV-2 genome
- It is more likely to keep doing well when new variations appear.
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Source : Food and Drug Administration, US
