{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2Fc39c3205-c544-4c9d-ab35-90f41e4d59af","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Latest Updates on CDRH Standards Program & IEC 60601","description":"Medical device standards seem to change and evolve all the time. Is it impossible to keep up with them? Do you know the latest and greatest when it comes to IEC 60601? FDA\u2019s CDRH standards program? Consensus standards database? FDA\u2019s ASCA pilot program?\n\nOn today\u2019s episode, we have Scott Colburn of the FDA and Leo Eisner of Eisner Safety Consultants to discuss what\u2019s currently happening in the medical device industry when it comes to standards.\n\n \nSOME OF THE HIGHLIGHTS OF THE SHOW INCLUDE:\n\u25cf New versions of IEC 60601 are in the works; every five years, standards are reviewed to address collaterals, issues, and recommendations.\n\n\u25cf Policy updates have been made regarding the appropriate use and recognition of voluntary consensus standards.\n\n\u25cf FDA values such standards because of consistency, predictability, and credibility of science-based decisions around patient safety.\n\n\u25cf FDA trains staff on standards and provides the medical industry with information on how to use FDA\u2019s programs - working together to improve use of standards.\n\n\u25cf Guidance is updated to be more efficient, consistent, and nimble: Process of recognizing and withdrawing standards.\n\n\u25cf Describing the changes made regarding declaration of conformity vs. general use of standard.\n\n\u25cf Some changes to standards are significant and affect requirements, such as updating normative references.\n\n\u25cf Declaration of Conformity is a legal statement that shows you followed a specific path and applied a standard in accordance with its intent.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/5c1b6410-ed86-4d8c-88c5-4a8465ec8ff4/c7cfd96a-d66c-46c1-a7b5-55d45b0d45ab.jpg"}