AdvaMedDx
In particular, new FDA requirements around modifying IVDs could lead labs to push for IVD vendors to validate their tests across a wider variety of use cases.
Dissatisfaction with the soon-to-be released FDA rule on LDTs has prompted legislators to reconsider the VALID Act and other possibilities for LDT oversight.
A divided Congress and the retirement of one of the VALID Act's most prominent supporters in the Senate could make passing the bill a difficult lift.
A few firms have made de novo or 510(k) submissions, but many are waiting as they continue to assess the market for their tests and look to the FDA for further guidance.
Is Abbott Antigen Test Answer to US COVID-19 Testing Problems? Stakeholders Emphasize Caution
Some lab experts say that Abbott's test is open to multiple variables, which could lead to improper use and incorrect test results.