A High-Level Overview of the Regulations Surrounding a Clinical Laboratory and Upcoming Regulatory Challenges for Laboratory Developed Tests.
Kevin C GradenShannon A BennettSarah R DelaneyHillary E GillMaria Alice Vieira WillrichPublished in: Laboratory medicine (2021)
An extensive discussion of proposed regulations for LDTs needs to occur. Laboratory testing requires the sustained use of innovative methods at a cost that will permit continued, timely, uninterrupted high-quality service.