The ACLA issued a 107-page comment letter that urges the FDA to drop its present proposal to rapidly regulate lab developed tests usings its 1976 medical device regulation.
See the press release here:
See the comment letter here:
The document kicks off with a four-page, 2500 word executive summary. The rule should be withdrawn for multiple policy and legal reasons. First, it would be significantly worse for patients. Second, the proposal profoundly misunderstands or mischaracterizes the lab industry ("based on flimsy and inaccurate data.") Third, the balance of costs and benefits is badly flawed. Fourth, the proposal is not legal; lab services are not "devices." While these seem enough to sink the rule, ACLA closes with some input on alternatives.
Commissoned Carrigan Report Dissects FDA Economics
The report concludes with a 26-page analysis of the flawed cost-benefit analysis by an economist. See an AI summary of those 26 pages, here. Note - this AI summary, and some AI Q&A, is the best I've seen.
NYS and MolDx
The report mentions both NY State and MOLDX as efficient review processes, unrelated to the strangeness of 1976 device law, that validate the accuracy of LDT tests. ACLA notes that MolDx has validated some 20,000 tests. See MolDx paragraphs extracted here.
I provide Chat GPT-4 and Claude.AI summaries of the 107 page document in a side bar, here: