In Brief: Device remarketing
This article was originally published in The Gray Sheet
Device remarketing: Comments on FDA's plans to revise its policies for regulating device remarketers are due by March 23, the agency says in a Dec. 23 Federal Register notice. The notice includes definitions of refurbishers, "as is" remarketers and servicers, and FDA seeks input on whether it should propose the definitions either in guidance or regulation. The definitions all include the criteria that the company does not "significantly change the finished device's performance or safety specifications or intended use." In addition, FDA is reevaluating the application of labeling, manufacturing, reporting and other requirements to remarketers. The agency also is "considering whether to propose rulemaking regarding modified registration, listing, and" good manufacturing practices requirements for remarketers, "or whether to make some or all of these three controls voluntary"...
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.