Lexology July 10, 2024
Now that the final rule on laboratory developed tests (LDTs) has been available for over a month and the stages of the enforcement discretion phaseout process and the Food and Drug Administration’s (FDA’s) newly proposed policies for continuing limited enforcement discretion for certain types of LDTs have been thoroughly described and dissected (including by us in our previous post), it’s high time to dig into FDA’s perspectives on the comments it received on the proposed rule.
Even though the revision to FDA regulations described in the rule is relatively short (recall that only 10 words are being added to one definition), the proposed rule generated over 6,500 comments from the public, and the agency’s summary of the comments and its...
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