Regulation and Compliance
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...
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...
When CDRH reworded the copyrighted ISO 9001 Quality Standard to update the Good Manufacturing Practice regulation in the 1990s, the primary objective was the addition of design control.1  It was reported by FDA that approximately half of all device and diagnostic recalls were due to design issues rather than manufacturing issues. Last September, the independent Battelle Memorial Institute issued a report for AdvaMed on the 510(k) premarket submission program and, among their conclusions,...
At the end of last year, Congress passed the FDA Food Safety Modernization Act, which will overhaul the U.S. food safety system and provide better protection against contaminated food and food-borne illnesses. President Obama eventually signed the act into law in early January.     This new food safety legislation proposes to do the following: •    Improve the prevention of food contamination through the identification of hazards before food becomes...
AdvaMed expects that the new House Republican majority and an increased number of Senate Republicans will drive a more aggressive Congressional role in overseeing and influencing the implementation of health reform and regulatory changes at FDA. On health reform implementation, this likely will entail oversight hearings, legislative initiatives to repeal and replace parts or all of the new law, and attempts to alter the Obama Administration’s regulations. With regard to FDA regulatory...
In July, FDA held a public meeting to discuss the agency’s oversight and regulation of laboratory-developed tests (LDT). During the two-day meeting, an overview of the history and current regulatory status of LDTs was discussed. The meeting was divided into four sessions: patient considerations, challenges for laboratories, direct-to-consumer marketing of testing, and education and outreach. Each session consisted of public presentations that focused on each area and was followed by an...
 FDA has thought about regulating laboratory developed tests (LDTs) for more than a decade. But this summer the likelihood of increased regulation appeared to move from possible to probable. In her presentation to the medical community on July 17, Elizabeth Mansfield from OIVD stated that while there is “no intention to disrupt [current] testing,” we should “plan for some re-assessment [of regulation] across the board.” We have become comfortable with a new...
In vitro diagnostics is, by many accounts, an underrated, undervalued industry. While pharmaceutical and therapeutic medical-device innovations tend to garner most of the mainstream media’s attention, the fact remains that 60 to 70% of medical decisions are influenced by some type of diagnostic testing, yet diagnostics accounts for only a tiny fraction of overall healthcare spending.  Some of the major developments within this very important industry during the past 15 years include...
During the 1990s, IVD regulation changed dramatically, and this development has accelerated even into the new century. Regulators and the IVD industry found agreement on quality system requirements and acceptance of ISO 13485 to cover design to post-market.1 These are major achievements and should not be undermined. Worldwide, the principles of classification of IVD medical devices, labeling requirements, risk management, and even medical event reporting have also been agreed on in principle....
In the fifteen years since the founding of IVD Technology, the IVD industry—and its regulation by FDA—have both changed. The diagnostic capabilities of IVDs have improved dramatically during that period. Some of the advances, such as high-speed, lower-cost genomic sequencing, seemed like the stuff of science fiction when IVD Technology was first published. The number of diagnostic uses has mushroomed during that same period, and IVDs are playing an increasingly important clinical...