Regulations & Standards
Manufacturing equipment and supplies
The good news is that in a stagnant economy, the $37 billion global IVD market continues to grow at a compound rate, which is expected to approach 9% through 2012. The challenging news is that IVD manufacturers encounter a myriad of obstacles when considering their manufacturing solutions. IVD testing devices are much more sensitive and complex than in the past. Not only is the technology more complex, stringent per-piece pricing adds to that complexity. There is an ever-constant need to reduce...
Revision of Europe’s IVD Directive 98/79/EC
The European Directive 98/79/EC on in vitro diagnostic medical devices, or IVD Directive (IVDD), became operational in June 2000.1 It provides Europe with one single regulation for in vitro diagnostics (IVD). Devices receiving the CE mark after one successful conformity assessment procedure can be introduced into the member states of the European Union and the European Free Trade Association, and two countries with which mutual recognition agreements have been established (Switzerland and...
Exploring FDA-Approved IVDMIAs
The sequencing of the human genome in 2001 brought about rapid development of technologies to measure multiple genes, which resulted in the creation of gene arrays. These tests, and multianalyte protein marker panels, constitute a new type of advanced diagnostic that is rapidly entering the clinical laboratory.1 As a result of the vast information that was made available from the Human Genome Project, great expectations developed that we would be able to diagnose, target, predict, and treat a...
Quality Control in Molecular Diagnostics
New information on proficiency results and quality practices points to a continued gap in the standard of quality control (QC) practice between molecular diagnostic testing and that of other laboratory disciplines. Indications of quality issues have surfaced in several areas but most visibly in the direct-to-consumer (DTC) testing arena. A recent Government Accounting Office study, for example, showed evidence of inadequate quality of molecular testing following an analysis of the results of...
Why manufacturers should embrace error grids
To legally sell in vitro diagnostic assays, manufacturers must submit performance data to FDA that demonstrates that the assay meets specifications. However, FDA approval does not guarantee that serious problems do not lurk within the assay that could cause severe patient harm and subsequent financial loss to the manufacturer. A typical performance specification has limits for average bias and imprecision. The logic of this specification is that according to a popular model, average bias plus...
Regulation of IVDs in Australia
Australia's Therapeutic Goods Administration (TGA) is planning to implement a new risk-based regulatory framework for in vitro diagnostic medical devices during 2010. The regulatory framework is based on the recommendations of the Global Harmonisation Task Force (GHTF). Australia will be the first GHTF founding member to implement a GHTF-based system for IVDs. The proposed framework will regulate IVDs as a subset of medical devices and will amend the current Therapeutic Goods (Medical Devices...
Laboratory Quality Control Based on Risk Management
Risk management is a new area of focus for the Clinical and Laboratory Standards Institute (CLSI). Three CLSI documents, EP18, EP22, and EP23, provide a foundation for clinical laboratories to develop quality control plans based on risk management. Risk management is defined as the systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk (ISO 14971).1 IVD manufacturers are familiar with risk management...
A taxonomy for medical device use error
People make mistakes all the time. To err is one of the well-recognized characteristics of being human. Alexander Pope is credited with having written, “To err is human, to forgive divine.” In our highly complex society, we might rightly expand on Pope to say, “To err is human; to really mess up takes a system with a convoluted user interface.” Unfortunately, in medical technology, as well as in other safety-critical systems, mistakes can lead to serious, often...
The Case for Regulating Laboratory-Developed Tests
Part one of this article, published in the November/December 2009 issue of IVD Technology, offered reasons why FDA should regulate laboratory-developed tests (LDT). Part two examines some reasons frequently given for not regulating LDTs and explains why each argument falls short of justifying FDA's inaction.   Imposing FDA regulation on LDTs would disrupt the use of important diagnostic tests   One rationale the agency has asserted is that, while it has the authority to regulate LDTs...
The Case for Regulating Laboratory-Developed Tests
For years, the IVD industry, clinical laboratories, and patient groups have debated the appropriate regulatory scheme for laboratory-developed tests (LDTs). More recently, FDA has ventured into the debate. For example, in addition to taking some enforcement measures, FDA issued the in vitro diagnostic multivariate index assay (IVDMIA) draft guidance and the revised analyte specific reagent (ASR) guidance, both of which strive to help draw the dividing line between LDTs and IVDs. FDA's...