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The FDA has warned Miami-based Trucare Biomedix-USA over slips on supplier audits, purchasing controls and other good manufacturing practices. Read More
Stryker and its OtisMed subsidiary must ante up more than $80 million for distributing knee replacement surgery cutting guides that had been denied FDA clearance. Parent Stryker will also establish a compliance program to ensure all marketed products have the necessary approvals. Read More
A proposed rule that would narrow how hospitals interpret the term “reduce or limit services” under the anti-kickback statute and civil penalties rules could hurt patient care by denying access to medically necessary treatments, industry says. Read More
Members of the House health subcommittee are asking devicemakers to weigh in on key issues around the regulation of laboratory-developed tests, including whether traditional concepts of safety and effectiveness should be applied to LDTs, as they consider an appropriate legislative response. Read More
India’s drug pricing control bureau wrote to 10 multinational device companies earlier this month demanding pricing information on cardiac and drug-eluting stents, orthopedic implants and other notified products. Read More
An FDA decision to allow multiple entities to issue unique device identifiers could backfire and actually impede the uptake of UDI, medical device and healthcare industry experts warned last week. Read More
The FDA is ratcheting up safety controls on infusion pumps, mandating that developers of new pumps follow stricter requirements for design validation and verification and provide more detailed applications to address safety hazards associated with pumps used in the home. Read More
The number of devicemakers that received warning letters from the U.S. Food and Drug Administration following quality system inspections decreased 12 percent in 2013, compared with the previous year — the first decline since 2009. Read More
Greiner Bio One Brasil Produtos ran afoul of the FDA after documenting design changes in informal meetings with informal notes, a recent warning letter shows. Read More