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Coronary device company HeartWare International said Wednesday that it received an FDA warning letter related to the company’s Miami Lakes, Fla., manufacturing facility. Read More
Manufacturers of some cellulite-reduction devices may have an easier time bringing their products to market, thanks to an FDA reclassification order. Read More
AdvaMed has hung up its shingle at an office in Shanghai, hoping to play a more proactive role in regulatory and reimbursement policies impacting devicemakers in China. Read More
The FDA’s process for developing guidance documents needs a major revamp to speed efforts along and integrate feedback from stakeholders earlier, devicemakers and CDRH officials concluded during a Thursday public workshop. Read More
Manufacturers of ultraviolent sunlamps used in tanning beds have 450 days to submit 510(k)s on lamps now in use, an FDA final reclassification order on the preamendment devices says. Read More
Manufacturers of combination products can expect draft guidance on current good manufacturing practices in the next several months, staffers in the FDA’s Office of Combination Products said. Read More
Argentina’s ANMAT has adopted strict traceability requirements for medical devices, with the aim of stemming the flow of counterfeit products. Read More
As 3D printing gains popularity among medical devicemakers, the FDA wants to get advice from manufacturers and researchers to guide its product reviews and, possibly, future guidance. Read More