Top Five Articles on 360Dx Last Week: FDA Guidance for COVID Tests; SALSA Reintroduction; and More
Last week, readers were most interested in a story about guidance issued by FDA for test developers seeking full market authorization for COVID-19 tests.
Congress Reintroduces SALSA, Taking up PAMA Reform Once Again
A top priority for the lab industry, the bill was reintroduced this week by bipartisan groups of legislators in both the House and Senate.
While reform of lab-developed test regulations and PAMA appeared possible at the beginning of 2022, in the end, the status quo won out.
Lawmakers are still wrangling over whether to include these two key lab industry bills in an end-of-year spending package due to pass next week.
Many hospital labs don't have the ability to effectively report lab price data, which could undermine SALSA's impact on PAMA's price-setting process.