Diathermy Interactions With Implanted Leads Cited In CDRH Health Notice
This article was originally published in The Gray Sheet
Executive Summary
Shortwave and microwave diathermy is contra-indicated in patients with implanted metallic leads, the Center for Devices & Radiological Health is warning
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FDA In Brief
Quality systems workshop: Firms should pre-register by June 7 for FDA's public workshop on how to comply with quality systems regulations, according to a Federal Register notice to be issued May 28. Organized by FDA in conjunction with the Office of Regulatory Affairs and the FDA Medical Device Industry Coalition, the workshop's target audience is regulated industry, particularly small businesses. Among the topics to be addressed are: analysis of FDA 483s and warning letters; the relationship between corrective and preventive actions and QSR and QSIT; designing and implementing CAPA; and the role of complaint files in a CAPA system. The workshop will be held July 19 in Dallas, Texas...