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Manufacturers of tanning bed ultraviolet and sunlamps that were offered for sale prior to Sept. 2, 2014, must submit 510(k)s to the FDA by Aug. 26. Read More
Foreign entities may now own up to 100 percent of an established Indian devicemaker without first getting government approval, under revisions to the country’s consolidated foreign direct investment policy. Read More
European lawmakers voted 402 to 118, with 171 abstentions, on Wednesday to require devicemakers that use tin, tantalum, tungsten or gold in their products to certify that the minerals aren’t sourced from certain conflict zones. Read More
A Virginia maker of implants used in plastic surgery was slapped with a warning letter after an FDA inspection found flaws with the company’s validation and MDR reporting practices. Read More
Negotiations on the fourth iteration of the Medical Device User Fee Act will swing into full gear July 13, with an FDA public meeting to assess the current MDUFA and ways to improve it. Read More
Devicemakers should develop a design flexible enough to allow for use outside the U.S. with modest revisions, the FDA's former chief UDI architect says. Read More
Devicemakers should expect to see the European Council’s final version of the proposed medical device and in vitro medical device regulations next month, an EU industry official says. Read More