Laboratory Stakeholders Urge FDA To Ditch IVDMIA Guidance, Pursue Rule
This article was originally published in The Gray Sheet
Executive Summary
FDA should start over in its efforts to claim regulatory oversight of a new class of high-tech laboratory-developed tests through a guidance document and begin a formal rulemaking process, diagnostic industry stakeholders said at a Feb. 8 hearing
You may also be interested in...
Lab Stakeholders Still Oppose FDA’s Multivariate Assay Policy
Laboratories are urging FDA to once again rework, if not abandon, its proposal to actively regulate certain lab-developed tests, while diagnostics companies are split on the issue
Lab Stakeholders Still Oppose FDA’s Multivariate Assay Policy
Laboratories are urging FDA to once again rework, if not abandon, its proposal to actively regulate certain lab-developed tests, while diagnostics companies are split on the issue
FDA Takes Second Stab At Multivariate Diagnostic Oversight Guidelines
FDA cautiously moved ahead with its controversial plan to actively regulate certain laboratory-developed tests with the release of a revised 1draft guidance document July 24