Devices & Diagnostics LetterThis is a must-read for leaders in the device and diagnostics industries who need to stay in compliance and avoid costly design and production mistakes. Each issue provides the latest regulatory news, including Part 11 compliance, software validation rules and other pre- and post-market requirements, and tells you how to slash research time, speed your products through the approval process and pass a facility inspection.FDA Grants 510(k) Clearance for Cardiac Bypass Surgery System- September 12, 2008 Cardica received FDA 510(k) clearance to market its PAS-Port proximal anastomosis system for use in coronary artery bypass graft (CABG) surgery.http://www.fdanews.com/newsletter/article?articleId=110348&issueId=11951 Researcher Failed to Get FDA Approval for Device Trial- September 12, 2008 A researcher conducted a clinical trial of an implanted device without getting FDA approval or informed consent, according to a warning letter.http://www.fdanews.com/newsletter/article?articleId=110346&issueId=11951 Need for MRI Questioned in Breast Cancer Patients- September 12, 2008 With the Centers for Medicare &38; Medicaid Services raising questions about the rapid growth and appropriate use of imaging services, MRI manufacturers should note that a new study says routine use of MRI scans to evaluate breast cancer may not be as beneficial as previously believed and may have several disadvantages.http://www.fdanews.com/newsletter/article?articleId=110349&issueId=11951 Spine Market Outgrows Abbott, Zimmer Takes Over- September 12, 2008 The spinal market has grown increasingly profitable, but compnay size is a crucial component to staying competitive, an Abbott spokesman said.http://www.fdanews.com/newsletter/article?articleId=110345&issueId=11951 Fall Prevention Warned for GMP, Complaint-Handling Violations- September 12, 2008 Fall Prevention Technologies was cited for failure to establish adequate quality system procedures for corrective and preventive action (CAPA), complaints, design controls and records, according to an FDA warning letter.http://www.fdanews.com/newsletter/article?articleId=110347&issueId=11951 FDA, University to Bridge Divide Between Research and Trials- September 12, 2008 The FDA and the University of Pennsylvania have signed a memorandum of understanding (MOU) to collaborate on research that will advance medical product development and the regulatory approval process.http://www.fdanews.com/newsletter/article?articleId=110344&issueId=11951 Sgarlato Cited for Lack of Quality Assurance Procedures- September 12, 2008 Sgarlato Laboratories filled an order for its Pain Free Pumps even though some of the devices were not tested before being shipped and others had expired before they were distributed, according to an FDA warning letter.http://www.fdanews.com/newsletter/article?articleId=110350&issueId=11951 Devicemakers Respond to Investigations, Improve Their Transparency- September 12, 2008 In response to industrywide investigations into financial relationships between doctors and medical device companies, some firms are ramping up their efforts to create more transparency.http://www.fdanews.com/newsletter/article?articleId=110343&issueId=11951 Isotope Shortage Worsens, Industry Looks for Solutions- September 12, 2008 An already strained global supply of medical isotopes is facing a new threat following the unexpected shutdown of the High Flux Reactor in Petten, Netherlands.http://www.fdanews.com/newsletter/article?articleId=110342&issueId=11951 FDA Reopens Comment Period for Hemostatic Device Draft Guidance- September 12, 2008 The FDA is reopening the comment period on a draft guidance and proposed rule pertaining to absorbable hemostatic devices.http://www.fdanews.com/newsletter/article?articleId=110351&issueId=11951 |