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The Centers for Medicare & Medicaid Services and U.S. FDA are establishing an interagency task force to address issues around the regulation of laboratory-developed tests, including LDT quality requirements. Read More
The U.S. FDA’s Center for Devices and Radiological Health is launching a public database of labeling for home use devices and is looking for devicemakers to help test it later this year. Read More
With a June 30 device registration deadline fast approaching, Malaysia’s Medical Device Authority has released more guidance for manufacturers working to list their products. Read More
Health Discovery Corp. may not make any misleading claims about an app purported to diagnose skin cancer, the U.S. Federal Trade Commission says in a final consent order issued April 13.
The consent order follows a February complaint and subsequent comment period. In the complaint, the FTC said there was no scientific data supporting the company’s claim that its MelApp product can evaluate moles for melanoma symptoms. Read More
The number of medical devices recalled in the U.S. during the final quarter of 2014 increased over the previous quarter despite an overall drop in the number of recall actions, a report from Stericycle Expert Solutions shows. Read More
Devicemakers should submit new electronic Medical Device Reports several days before the deadline or risk being considered late under U.S. FDA requirements that take effect Aug. 14. Read More
Devicemakers whose instructions for use are flawed or poorly written could see them flagged by the UK’s Medicines and Healthcare products Regulatory Agency as adverse events. Read More
Devicemakers doing business in the Czech Republic face a steeper regulatory burden than before, thanks to regulations that took effect April 1. Read More