Regulation and Compliance
IOM’s recommendation to replace 510(k) fails to win support
Back in late July of this year, the Institute of Medicine (IOM) recommended that FDA replace the 510(k) medical-device clearance process with something brand new. (Under current regulation, to obtain 510(k) clearance, a manufacturer must demonstrate that the device is substantially equivalent to a device that was in legal commercial distribution in the United States before May 28, 1976, or to a device that has been determined by FDA to be substantially equivalent.) The committee stated that FDA...
FDA releases guidance on companion diagnostics
FDA released its draft guidance on in vitro companion diagnostic devices. The guidance is intended to assist companies that are planning to develop a drug that depends on the use of a companion diagnostic for its safe and effective use as well as those companies that are planning to develop a companion diagnostic that is intended to be used with a corresponding drug. Industry analysts were positive in their overall assessments of the guidance. “The draft guidance is helpful in several...
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...
FDA scrutinizes DTC genetic tests
In March, FDA’s Molecular and Clinical Genetics Panel held a meeting to discuss and make recommendations on scientific issues concerning direct-to-consumer (DTC) genetic tests that make medical claims. FDA opened the meeting with a presentation outlining the history and landscape of DTC clinical genetic tests. FDA ended its introductory presentation by providing the current challenges and rationale for the meeting: to hear perspectives from broad panels of experts, invited...
Lukewarm Response to FDA’s Proposed Innovation Pathway
Reactions to FDA’s proposed Innovation Pathway, part of its new Medical Device Innovation Initiative, are mixed. The Innovation Pathway, if instituted, will be a “priority program for new, breakthrough medical devices,” according to FDA. It is one component of a broader effort by CDRH to “encourage cutting-edge technologies among medical device manufacturers.” The first product submission for this review program is a robotic prosthetic arm being developed by DARPA...
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...
Measuring Regulatory Effectiveness
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,...
Congress Passes Food Safety Law
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...
Examining the election fallout
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...