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Device Ombudsman Lists ComplaintsThe CDRH reports a 44 percent increase in complaints compared with 2010, and lists other contacts that the agency had with the public last year. |
New Regulations Imminent in Russia Russian authorities are expected to implement new medical device regulations concerning authorized representation, vigilance, country-of-origin approval and other issues within the next several weeks. |
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FDA Looking to Partner with Industry Groups Agency announces working together with Biocom in an effort to speed up review process for devices; CDRH chief also calls for more collaboration in medical devices industry. |
FDA Misses Deadline The U.S. Food and Drug Administration has missed a legal deadline to submit a proposal for Congressional approval over the cost of speeding up product reviews starting this year. |
U.K. Implant Danger Widespread The threat of substandard implants is widespread and points to a flawed device approval system, U.K. experts feel; in recent development, surgeons have issued definitive guidance to women with PIP implants. |
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Reporting on Pediatric Devices "Inconsistent" The Government Accountability Office has recommended that FDA collect reliable information to report data on pediatric medical devices by consistently using its existing electronic flags in its tracking system or otherwise developing internal controls. |
Cook Medical Invests $20M in Irish R&D Cook Medical has announced plans to invest, over the next four years, up to €16.5 million ($20 million) in its Limerick, Ireland site, with government support through IDA Ireland. |
“FDA is Slowing Growth” Eight out of 10 California’s biomedical CEOs feel that cumbersome FDA processes is one of the biggest threats to growth. |
More Vaginal Mesh Safety Studies NeededFDA has asked Johnson & Johnson, C.R. Bard, Covidien, Boston Scientific and several other companies to conduct three-year studies on the safety and effectiveness of the meshes. |
FDA Addresses Reusable Medical Devices After receiving reports of patient exposure to microscopic amounts of blood and tissue left behind on equipment that wasn't properly cleaned, the agency renews focus on reprocessing of devices. |
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Less Money for Med-tech Start-upsNationwide survey finds that 58 percent of early-stage investors predict that there will be fewer investments in biopharmaceutical and medical device businesses. |