本次美国食品药物管理局的Medical Devices：Laboratory Developed Tests final rule 的执行及缓冲时间将分为...
The U.S. Food and Drug Administration (FDA or Agency) announced on April 29, 2024, in a forthcoming and long-awaitedfinal rulethat laboratory developed tests (LDTs) will be regulated as medical devices. LDTs arein vitrodiagnostic products (IVDs) that are intended for clinical use a...
doi:10.1093/clinchem/hvae104Wijk, Xander M R vanMaster, Stephen RGenzen, Jonathan RClinical Chemistry
On April 29, 2024, the US Food and Drug Administration (FDA) issued a long-awaited final rule asserting its authority to regulate laboratory-developed tests (LDTs) as medical devices. If the rule goes into effect, there will be major impacts on clinical laboratories offering LDTs. ...
Personalized or precision medicine relies on accurate diagnostic tests. The U.S. Food and Drug Administration's (FDA) recent final rule...
laboratory." The move, which proposes adding language to21 CFR § 809.3, initiates notice-and-comment rulemaking on a matter garnering both strong opposition and support. If adopted, the rule would considerably shift FDA's approach to laboratory developed tests ("LDTs"), with significance not ...
The FDA warning letter to Agena marks a shift in enforcement, targeting the improper labeling of laboratory-developed tests and RUO products without approval.
FDA’s Proposed Rule for Oversight of Laboratory Developed Tests: Part II: FDA’s Proposed Phaseout Policy – Key Considerations & Open Questions
Federal Register, Final Rule FDA: Laboratory Developed Tests FDA: LDT Frequently Asked Questions Media Contact:Jim McKinney, 240-328-7305 Consumer Inquiries: 855-543-3784 The FDA, an agency within the U.S. Department of Health and Human Services, protects the pub...
美国食品与药品监督管理局(FDA)发布了期待已久的Quality Management System Regulation (QMSR) Final Rule《质量管理体系法规》最终规则,目标是与国际标准化组织(ISO)广泛认可的标准协调一致。FDA表示,这项规则的制定,是其为促进设备监管一致性而采取的最新行动,预计每年将为行业节省数亿美元。