Regulatory News In Brief
Hemostat devices: Absorbable hemostat device manufacturers Johnson & Johnson/Ethicon and Danish firm Ferrosan have until June 7 to submit updated comments to FDA in opposition to a proposed down-classification of the products, which consist of wound dressing and a chemical or biological agent used to control bleeding during surgical procedures. The agency reopened the comment period after it expired in January in response to requests from the two firms for more time. The companies, which market Surgicel (Ethicon), Instat (Ethicon) and Surgifoam (Ferrosan), have already gone on the record against the reclassification, which would allow new products to enter the market based on 510(k) clearance rather than the more involved PMAs that were required for their products. FDA proposed the reclassification in October 2006 after two advisory panel meetings in 2002 and 2003. Ethicon and Ferrosan argue that FDA has not been transparent enough in its proposed rulemaking and that the suggested policy's product definition is too broad, among other issues...
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A framework to end the Iran war is in place but fractured supply chains can’t recover overnight. Data from India suggests solvent prices have generally cooled from April peaks, but API costs stay elevated or even climbed in June for some products.
REUSE OF DISPOSABLE CARDIAC CATHETERS TARGETED BY FDA in an effort to address safety concerns about reuse of single-use products. The cardiac catheter product area "seems to jump up as one that is an area for us to focus on," Larry Spears, director of the Office of Compliance's Division of Enforcement III in FDA's Center for Devices and Radiological Health, said June 24 at a Food Drug and Law Institute conference held in Washington, D.C.
St Jude Medical and Spire are to develop anti-bacterial heart valve sewing cuffs using Spire's Spi-Argent silver coating process. The agreement covers a variety of valve designs as well as ancillary components. The treatment is aimed at reducing the incidence of endocarditis, a rare but dangerous complication of valve transplant which has a mortality rate as high as 60%.
Nissho saw sales rise only 1% to ¥17 billion ($930 million) in the year to March 1997. The Japanese company's net income was Yen3 billion, compared with Yen1.7 billion for the previous year, reports Reuters. Nissho produces disposable medical equipment.
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Class III devices and panel-track supplements approved by US FDA’s Center for Devices and Radiological Health. Data derived from FDA.gov. Updated weekly.
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