Education & Information
In 2008, The OHRP (HHS) provided guidance as to when research involving coded private information or specimens is or is not research involving human subjects, as defined under HHS regulations for the protection of human research subjects (45 CFR part 46).
FDA proposes a new option for 510(k) clearance that will modernize the FDA’s approach to moderate risk devices by allowing manufacturers to use objective performance criteria to facilitate demonstration of substantial equivalence of their new products to legally marketed devices.
“Right now, manufacturers often rely on comparative testing against predicate devices to show that a new device is as safe and effective as a predicate device. But these predicates can be old, and in certain cases, they might not closely reflect the modern technology embedded in new devices. By allowing a set of objective, transparent and well-validated performance metrics to serve as the benchmark for evaluating some new devices, this new pathway offers a more efficient and less burdensome option to demonstrate that certain new devices are substantially equivalent to ones already on the market,” said FDA Commissioner Scott Gottlieb, M.D.
All manufacturers who wish to market devices in the United States are required to register with the FDA and are subject to periodic audits. This article describes the marketing pathways they can choose.
The legal, ethical and scientific basis for aggregating, sequestering and distribution of human biospecimens for research purposes has been well debated for the past 50 years and most recently re-visited by an HHS rulemaking committee in 2016. Any modifications to existing rules were firmly argued against by nearly every academic, industrial and private research group in the United states.
There’s nothing flashy about specimen tubes, which may look like the most mass-produced, commonplace items in the laboratory, but appearances can be deceptive. All tubes are not created equal. “We know that pre-analytical errors account for the majority of errors in the laboratory, and many of those errors derive from the tube type in which you collect your sample,” says Leslie J. Donato, PhD, co-director of the hospital clinical laboratory and point of care at the Mayo Clinic in Rochester, Minn.