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A new DNA sequencing test that detects extra or missing fetal chromosomes has results comparable to standard clinical tests, is less expensive and can be done at the point of care in one day, according to a study led by researchers at New York’s Columbia University.
The FDA said it has received 44 more reports of deaths associated with the June 2021 recall of millions of Philips’s continuous positive airway pressure (CPAP), bi-level positive airway pressure (BiPAP) and ventilator devices.
Regulatory bodies in the U.S. and internationally put a great deal of emphasis on supplier control, a critical part of a devicemaker’s quality management system. Suppliers are supposed to act as an extension of the devicemaker’s own quality control system, meaning that companies must be able to trust that their suppliers are producing and delivering goods that meet all regulatory requirements, as well as any device-specific requirements spelled out in the supply contract.
When it comes to blood pressure monitoring at home, old-fashioned blood pressure cuffs work just as well as newer, app-based technology, researchers reported in the journal JAMA Internal Medicine. Read More
Sunnyvale, Calif.-based molecular diagnostics company Cepheid is embroiled in a controversy over access in developing countries to its tuberculosis diagnostics test, which was funded in part by the World Health Organization (WHO). Read More
The FDA has updated its guidance for manufacturers of in vitro diagnostic devices who want to use a previously cleared instrument assay, or replacement reagent, on another instrument, providing information on when and how to determine if a new 510(k) application is needed. Read More
Manufacturers should provide better information about specific risks and directions for use of hydrogen peroxide-based contact lens care products (HPCPs), the FDA said in a draft guidance released yesterday. Read More
Although a quality agreement is not specifically required or defined in FDA regulations, the FDA may ask during an inspection to review any documents that describe the way you manage contract service providers. Read More
The FDA has published a landmark final rule that creates a new category of over-the-counter (OTC) hearing aids aimed at improving access and lowering the cost of the devices. Read More