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The Senate late Saturday approved a spending bill that gives the FDA just over $420 million in medical device and diagnostics regulatory funding, a slight drop from current levels. Read More
Inadequate CAPA procedures led all other causes for Form 483s issued to devicemakers in fiscal 2014, while purchasing control issues jumped from sixth place to third in the FDA’s annual ranking of inspection observations. Read More
A Government Accounting Office review of Medicare’s competitive bidding program shows that payment amounts for a sample of 28 Healthcare Common Procedure Coding System codes generally decreased during all bidding rounds, compared with the average fee-for-service payment for the same codes in 2010. Read More
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