HEADER. I was very impressed by a 58-page FDA LDT comment, submitted by Hyman Phelps law firm and an LDT Coalition.
The biggest splash I know of, among FDA LDT comments in December, was that of the ACLA, which was some 100 pages when including an extensive supplement in which an economist took apart the FDA's proposed financials. ACLA entry point here.
Here's another grand example. it comes from Hyman Phelps McNamara and the Coalition to Preserve LDT Access and Innovation. Find it here:
- Prohibitive costs of the rule
- Poor presentation of LDT risks and no presentation of LDT benefits
- Deeply flawed economic analyses
- Multiple categories of costs ignored and underestimated
- Existing regulatory framworks are ample
- FDA lacks statutory authority
- Elaborate statutory discussion
See also the firm's Feb 2 essay, on the holes in the FDA's Jan 31 press release about IVD reclassification.