In brief, LDTs are in vitro diagnostics (IVDs) that are intended for clinical use and are designed, manufactured, and used within laboratories that are certified under the Clinical Laboratory ...

The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for laboratory-developed ...

This article is the third in Microbiologics’ series on Optimal QC in the Clinical Laboratory. Previously, in this series we highlighted the importance of external and third-party quality control ...

The new EU In-Vitro Diagnostic Regulation shifts IVDs to a patient impact-focused risk classification, necessitating conformity assessments for 80% of devices, which presents opportunities for ...

Regulatory oversight has instead been exercised by the NAFDAC pursuant to its general mandate under the NAFDAC Act (Cap N1, ...

Since the 2017 publication of the medical device regulation (MDR) and the IVD regulation (IVDR), EU regulations for medical devices and IVDs have undergone a profound change. Manufacturers are now ...

Certification for two in-vitro diagnostic (IVD) products - the CupiKIT HIV 1&2 Antibody Test Kit and the CupiKIT Hepatitis B Surface Antigen (HBsAg) Test Kit.

Significant changes to EU digital health regulation lie ahead this year, Mason Hayes & Curran has highlighted. The business ...