Electrode lead wire reg based on international standards sought by device manufacturers.
This article was originally published in The Gray Sheet
PATIENT ELECTRODE LEAD WIRE REGULATION BASED ON VOLUNTARY STANDARDS is recommended by Medtronic, Bard, and 3M Health Care in recent comments on FDA's proposed mandatory performance standard for the devices. "In lieu of a mandatory performance standard," Medtronic says, FDA should require manufacturers of electrode lead wires to "certify that their leads comply with a recognized voluntary standard when a device is reviewed through the 510(k)" or premarket approval process.
You may also be interested in...
The Environmental Working Group and Scientific Analytical Institute say inadequate testing of talc-containing personal-care products is to blame for findings of asbestos in cosmetics, including three of 21 powder-based cosmetics SAI analyzed at EWG’s request. They continue to push for updated testing standards that include electron microscopy as a core component.
Can Atlas Biomed unlock Japan's self-care market with its direct-to-consumer DNA and microbiome tests? HBW Insight catches up with the company's co-founder and CEO to discuss this and also how Atlas has been driving its European expansion plans despite coronavirus.
France's ANSES warns women using oral contraceptives not to use a supplement marketed by UK firm Hairburst after linking the product's consumption to two cases of severe acute hepatitis.