scholarly journals European Symposium on the Clinical Laboratory and In Vitro Diagnostics Industry, 22–23 March 2001, Palma de Mallorca, Spain

2001 ◽  
Vol 23 (2) ◽  
Keyword(s):  
Clinical Laboratory ◽  
European Symposium ◽  
In Vitro Diagnostics ◽  
Palma De Mallorca

Regulation of in vitro diagnostics (IVDs) for use in clinical diagnostic laboratories: towards the light or dark in clinical laboratory testing?

2011 ◽  
Vol 49 (12) ◽  
Author(s):  
Emmanuel J. Favaloro ◽  
Mario Plebani ◽  
Giuseppe Lippi
Keyword(s):  
Clinical Laboratory ◽  
Regulatory Process ◽  
Adverse Outcomes ◽  
Personal Health ◽  
In Vitro Diagnostics ◽  
Clinical Diagnostic ◽  
In Vitro Diagnostic ◽  
The Usa ◽  
Clinical Laboratory Testing

AbstractA revised framework for the regulation of in vitro diagnostic devices (IVDs) came into force in Australia on July 1, 2010 that aims to ‘ensure that public and personal health are adequately protected’, but which instead may lead to adverse outcomes in clinical diagnosis and management. The regulatory process aims to regulate all IVDs, including those used by clinical diagnostic laboratories, which are already subject to scrutiny as part of the current laboratory accreditation process. The IVD regulatory process initiated in Australia is similar to that used in Canada, but different to that currently operating in the USA and Europe. However, it is feasible that other countries will in time adopt a similar regulatory framework, given that many countries are involved in the development process. In this opinion paper, the regulatory process for IVDs across several geographies are outlined, as are some benefits and weaknesses of the new regulatory process now applied to Australia, as potentially planned for other regions of the world.

scholarly journals Laboratory-Developed Tests: A Legislative and Regulatory Review

2017 ◽  
Vol 63 (10) ◽  
pp. 1575-1584 ◽  
Author(s):  
Jonathan R Genzen ◽  
Jeffrey S Mohlman ◽  
Jerry L Lynch ◽  
Michael W Squires ◽  
Ronald L Weiss
Keyword(s):  
Clinical Laboratory ◽  
Draft Guidance ◽  
In Vitro Diagnostics ◽  
Regulatory Oversight ◽  
Regulatory Review ◽  
Policy Documents ◽  
Congressional Hearings ◽  
Clinical Laboratory Improvement Amendments ◽  
Intense Debate

Abstract BACKGROUND Twenty-five years ago, the Food and Drug Administration (FDA) asserted in a draft document that “home brew” tests—now commonly referred to as laboratory-developed tests (LDTs)—are subject to the same regulatory oversight as other in vitro diagnostics (IVDs)4. In 2010, the FDA began work on developing a proposed framework for future LDT oversight. Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation. While the proposed guidance has not been implemented, many questions regarding LDT oversight remain unresolved. CONTENT This review provides an overview of federal statutes and regulations related to IVDs and clinical laboratory operations, with a focus on those potentially applicable to LDTs and proposed regulatory efforts. Sources reviewed include the Code of Federal Regulations, the Federal Register, congressional hearings, guidance and policy documents, position statements, published literature, and websites. SUMMARY Federal statutes regarding IVDs were passed without substantive evidence of congressional consideration toward the concept of LDTs. The FDA has clear oversight authority over IVD reagents introduced into interstate commerce. A 16-year delay in publicly asserting FDA authority over LDTs, the pursuit of a draft guidance approach toward oversight, and establishment of regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) applicable to LDTs contributed to community uncertainty toward LDT oversight. Future regulatory and/or legislative efforts may be required to resolve this uncertainty.

scholarly journals Laboratory Automation: Trajectory, Technology, and Tactics

2000 ◽  
Vol 46 (5) ◽  
pp. 764-771 ◽  
Author(s):  
Rodney S Markin ◽  
Scott A Whalen
Keyword(s):  
Process Control ◽  
Clinical Laboratory ◽  
Healthcare Delivery ◽  
Computer Integrated Manufacturing ◽  
Automation System ◽  
Laboratory Automation ◽  
In Vitro Diagnostics ◽  
Laboratory Services ◽  
Automation Technology

Abstract Laboratory automation is in its infancy, following a path parallel to the development of laboratory information systems in the late 1970s and early 1980s. Changes on the horizon in healthcare and clinical laboratory service that affect the delivery of laboratory results include the increasing age of the population in North America, the implementation of the Balanced Budget Act (1997), and the creation of disease management companies. Major technology drivers include outcomes optimization and phenotypically targeted drugs. Constant cost pressures in the clinical laboratory have forced diagnostic manufacturers into less than optimal profitability states. Laboratory automation can be a tool for the improvement of laboratory services and may decrease costs. The key to improvement of laboratory services is implementation of the correct automation technology. The design of this technology should be driven by required functionality. Automation design issues should be centered on the understanding of the laboratory and its relationship to healthcare delivery and the business and operational processes in the clinical laboratory. Automation design philosophy has evolved from a hardware-based approach to a software-based approach. Process control software to support repeat testing, reflex testing, and transportation management, and overall computer-integrated manufacturing approaches to laboratory automation implementation are rapidly expanding areas. It is clear that hardware and software are functionally interdependent and that the interface between the laboratory automation system and the laboratory information system is a key component. The cost-effectiveness of automation solutions suggested by vendors, however, has been difficult to evaluate because the number of automation installations are few and the precision with which operational data have been collected to determine payback is suboptimal. The trend in automation has moved from total laboratory automation to a modular approach, from a hardware-driven system to process control, from a one-of-a-kind novelty toward a standardized product, and from an in vitro diagnostics novelty to a marketing tool. Multiple vendors are present in the marketplace, many of whom are in vitro diagnostics manufacturers providing an automation solution coupled with their instruments, whereas others are focused automation companies. Automation technology continues to advance, acceptance continues to climb, and payback and cost justification methods are developing.

scholarly journals Regulation of Laboratory-Developed Tests

2019 ◽  
Vol 152 (2) ◽  
pp. 122-131 ◽  
Author(s):  
Jonathan R Genzen
Keyword(s):  
Clinical Laboratory ◽  
Leading Edge ◽  
Regulatory Reform ◽  
The United States ◽  
In Vitro Diagnostics ◽  
Regulatory Oversight ◽  
Clinical Laboratories ◽  
Legislative Proposals ◽  
Key Issues

Abstract Objectives To provide a clinical laboratory perspective on the Verifying Accurate Leading-edge IVCT Development Act (VALID) discussion draft. This potential legislative effort, if enacted, would overhaul the regulatory oversight of in vitro diagnostics (IVDs) in the United States and create a single system for regulation of conventional IVDs and laboratory-developed tests (LDTs). Methods A concise literature-based review of LDT regulation is presented followed by a discussion of key concerns pertinent to clinical laboratories that should be considered in future IVD regulatory reform efforts. Results Key issues identified include the importance of fostering innovation, preserving patient safety, protecting the practice of laboratory medicine, and minimizing undue regulatory burden. Clinical laboratories are not equivalent to manufacturing facilities and would therefore encounter challenges in implementing device-centric regulatory oversight models. Conclusions It is imperative that a clinical laboratory perspective on LDTs is understood and incorporated prior to advancement of future legislative proposals.

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