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China’s State Council last month approved the Medical Device Regulations (Amendment Bill), framework, paving the way for broad changes in device classification, adverse event reporting and monitoring of quality in device manufacturing. Read More
The Centers for Medicare & Medicaid Services should ensure that patients receiving care through the new Accountable Care Organizations are not denied innovative treatments due to cost, AdvaMed says in comments to CMS Administrator Marilyn Tavenner. Read More
Devicemakers will be able to distribute a wider range of clinical practice guidelines and medical textbooks to physicians under loosened FDA restrictions for off-label promotion. Read More
St. Jude’s Sylmar, Calif., plant, which makes most of its CRM products, should soon emerge from an FDA warning letter, CEO Dan Starks said on the company’s earnings call last month. Read More
The FDA’s draft guidance on 510(k) submissions for nucleic acid-based HLA test kits has raised concerns about manufacturing delays for new test kits and increased costs for devicemakers. Read More
The reorganization of CDRH’s Office of Compliance and creation of a Division of Manufacturing Quality has provided a shot in the arm to the center’s Case for Quality Initiative — fueling two pilot programs designed to increase inspection efficiencies without sacrificing quality, OC Director Steve Silverman says. Read More
The FDA is asking healthcare providers to report adverse events related to Teleflex Medical’s ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port. Read More
Devicemakers should take steps now to secure a production account for submitting electronic medical device reports ahead of an Aug. 14, 2015 deadline for compliance with mandatory eMDRs. Read More