{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2Fdbbd3eef-c990-4150-a462-2ea8fe3f392e","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"<iframe style=\"width: 100%; height: 200px;\" title=\"Looking at the Sunset of FDA's Alternative Summary Reporting Program\" frameborder=\"0\" scrolling=\"no\" allow=\"clipboard-write\" seamless src=\"http://player.captivate.fm/episode/dbbd3eef-c990-4150-a462-2ea8fe3f392e\"></iframe>","title":"Looking at the Sunset of FDA's Alternative Summary Reporting Program","description":"The FDA recently decided to discontinue its alternative summary reporting program due to the allegation that millions of medical device reports (MDRs) that included product-related malfunctions were \u201chidden\u201d and not disclosed to the public.\n\nIn this episode, Mike Drues of Vascular Sciences joins the show to discuss the pros and cons of the program and what\u2019s expected to happen because of its discontinuation.\n\nSome of the highlights of the show include:\n \n\u25cf\tDepending on severity of malfunction, the program gave companies a specified amount of time to report it as part of a summary.\n\u25cf\tWhat created controversy, and why was program cancelled? Potentially fake news headlines, checkbox mentality, and regulatory micromanagement.\n\u25cf\tWith or without a formal FDA program, companies should follow best practices and not wait for regulations to tell them when and what to do.\n\u25cf\tDid program \u201chide\u201d information? Instead, it reduced redundancy and created a more efficient way to report information. \n\u25cf\tFDA needs to clearly identify what events need to be reported; encourage companies to investigate and act to minimize or prevent future problems. \n\u25cf\tQuality and Regulatory vs. Product Liability Perspective: Documentation is critical or the kiss of death. There\u2019s never enough publicly available information.\n\u25cf\tSpecial 501(k) program will replace alternative summary reporting program to allow some companies to submit summary reports via spreadsheets.\n\u25cf\tQuality over Quantity: More isn\u2019t always better. Program cancellation could do more harm than good and offers opportunity to truly \u201chide\u201d information.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/9c046cc3-248b-4115-9472-a267414748fa/bb54f6dc-5734-4966-b1d5-f6ae172211ec.jpg"}