Since the announcement of FDA's intention to begin active oversight of laboratory-developed tests (LDTs) as medical devices, the industry and regulators have argued over authority, competency, bandwidth, and vocabulary. Public comments have been varied but heavy on dismay, anger, and confusion over how thousands of small labs, proverbial square pegs with limited resources, could ever hope to meet the expensive and time-consuming requirements of FDA's rules for Medical Devices (decidedly round holes).
At the crux of the matter is the fact that reagent manufacture, diagnostic test development, test performance, and the interpretation of results, test performance, and physician consultation are completely separate processes. LDTs yield information and these information-generating processes cannot feasibly be treated as an entity like artificial knees, stents, scopes, and scalpels.
Of course, the best argument is a solution-based argument: I see your problem, adversary, I understand your goal, but respectfully--your solution will never work. Here's a way we can achieve our mutual goals without destroying our industry or sacrificing your mission.
The Diagnostic Test Working Group (DTWG), comprised of ARUP Labs, LabCorp, Mayo Labs, Becton Dickinson, and Roche, has made just such an argument in A Proposed Regulatory Framework for In Vitro Clinical Tests. In this proposal, the DTWG suggests the extent of in vitro clinical test (IVCT) regulation should be in direct proportion to the risk and intended use of each test.
It's a rather beautiful thing--any laboratorian who has read the regulations and guidances surrounding medical devices and the failed IVDMIA has developed a headache just from trying to relate what we do to what the guidances are asking of us. In contrast, the DTWG's proposal acknowledges the differences between Test Development, Laboratory Operations, and Medical Application and suggests these processes be regulated separately, by FDA, CMS, and the states, respectively. They also suggest establishing a new center at FDA, specifically for the purpose of regulating IVCTs--thus avoiding the square peg/round hole problem.
Other commentary on the proposal can be found here and here.
At the crux of the matter is the fact that reagent manufacture, diagnostic test development, test performance, and the interpretation of results, test performance, and physician consultation are completely separate processes. LDTs yield information and these information-generating processes cannot feasibly be treated as an entity like artificial knees, stents, scopes, and scalpels.
Of course, the best argument is a solution-based argument: I see your problem, adversary, I understand your goal, but respectfully--your solution will never work. Here's a way we can achieve our mutual goals without destroying our industry or sacrificing your mission.
The Diagnostic Test Working Group (DTWG), comprised of ARUP Labs, LabCorp, Mayo Labs, Becton Dickinson, and Roche, has made just such an argument in A Proposed Regulatory Framework for In Vitro Clinical Tests. In this proposal, the DTWG suggests the extent of in vitro clinical test (IVCT) regulation should be in direct proportion to the risk and intended use of each test.
It's a rather beautiful thing--any laboratorian who has read the regulations and guidances surrounding medical devices and the failed IVDMIA has developed a headache just from trying to relate what we do to what the guidances are asking of us. In contrast, the DTWG's proposal acknowledges the differences between Test Development, Laboratory Operations, and Medical Application and suggests these processes be regulated separately, by FDA, CMS, and the states, respectively. They also suggest establishing a new center at FDA, specifically for the purpose of regulating IVCTs--thus avoiding the square peg/round hole problem.
Other commentary on the proposal can be found here and here.
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