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EU devicemakers are asking the European Council to replace the Commission’s scrutiny of notified body procedure in the proposed medical device regulations with a “reinforced control procedure.” Read More
The China Food and Drug Administration last month unveiled long-awaited reforms to its medical device regulations, breathing longer life into product licenses, but imposing first-time fees for device registrations. Read More
The Centers for Medicare & Medicaid Services is mostly consistent in selecting suppliers and computing single payment amounts in the competitive bidding program for durable medical equipment (DME), but the agency needs to ensure that all bids from winning suppliers are included in the calculation of single payment amounts before offering contracts, a report recommends. Read More
A Texas jury has ordered Johnson & Johnson to pay $1.2 million to a woman who alleged that a vaginal mesh implant used to treat incontinence eroded inside her, causing pelvic pain. Read More
A new combination product to treat opioid overdose has garnered FDA approval, in what appears to be an effort by the agency to fight charges of indifference to opioid abuse issues. Read More
Devicemakers shouldn’t expect mHealth guidance from the FDA until the agency has more stakeholder input on this month’s draft proposal on the regulation of medical software. Read More
The FDA is reopening the public comment period on a 2010 draft guidance on infusion pumps, highlighting its adjusted time estimate for manufacturers to submit case assurance reports. Read More
Attorneys for Ivy Sports Medicine told a federal judge Tuesday that the FDA did not have authority to reconsider and rescind a classification decision on ReGen Biologics’ Menaflex collagen scaffold device. Read More