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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Manufacturers of combination products can expect draft guidance on current good manufacturing practices in the next several months, staffers in the FDA’s Office of Combination Products said.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
CINCINNATI — CDRH’s Office of Compliance expects to begin work on a public database of device quality information, such as MDR reports, by the end of the year, OC Director Steven Silverman told devicemakers May 7 at the FDA/Xavier University MedCon conference. Read More
CINCINNATI — With September’s deadline for displaying unique device identifiers on high-risk devices just around the corner, rollout for many manufacturers is well underway. Read More
Routine quality system surveillance inspections of foreign devicemakers increased by 93 percent in 2012, according to newly released FDA data. Read More
Lawyers are advising devicemakers preparing conflict mineral reports due to the Securities and Exchange Commission this month to put more effort into describing their compliance with the Organisation for Economic Co-operation and Development’s due diligence guidelines. Read More