{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2Fa80b34d1-04ea-47e4-9b71-142dc61bb8d5","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Post-Pandemic Readiness: Preparing for the Aftermath of COVID-19 on the Medical Device Industry","description":"Are you prepared for the aftermath of the pandemic\u2019s impact on the medical device industry? It may be time for device professionals to start bracing for a new normal.\nIn this episode of the Global Medical Device Podcast, Jon Speer talks to Steven Niedelman and Eric Henry from King & Spalding LLC about post-pandemic readiness for the medical device industry and how companies can prepare for and embrace the new medical device landscape that\u2019s expected to take shape from 2021 onward.\nSteven, a former FDA deputy associate commissioner and COO for the agency\u2019s Office of Regulatory Affairs currently serves alongside Eric as the Quality Systems and Compliance lead consultants in the FDA and Life Sciences practice of their law firm.\nWith more than 50 years of combined industry experience between Steven and Eric, the insights and knowledge of this episode\u2019s guests, specifically as it relates to this topic is a MUST listen for any medical device professional.\nSome of the highlights of the show include:\nSteven and Eric discuss how COVID is pushing the FDA toward a voluntary pilot program for agency investigators to conduct virtual facility inspections.\nSteven describes the current state of FDA inspections as challenging to work remotely and conduct follow-ups when appropriate. The FDA has established a paradigm to continue on-site mission critical inspections.\nEric expands on the logistical challenge for inspections by explaining that since the FDA has put a hiatus on its inspection scheme, many organizations are following the Medical Device Single Audit Program (MDSAP).\nThe Medical Device Coordination Group\u2019s (MDCG) 2020-4 Guidance lists four circumstances where organizations under MDSAP or EU notified bodies have remote audits\u2014surveillance, re-certification, change notification, and termination.\nImpact of the Emergency Use Authorization (EUA) program and the influx of requests on FDA. Some EUA submissions require pre-approval inspections.\nBefore EUAs are revoked, build a remediated QMS, prepare for inspection, and decide whether to continue manufacturing a product after the pandemic.\nKing & Spalding\u2019s FDA and Life Sciences team offers a full-service approach, including cardiologists to help with health assessment risks, premarket and postmarket mergers and acquisitions, and warning letters.\nPre-submission is an initial but formal way to build communication, collaboration with the FDA. A pre-submission can be an effective means for understanding regulatory requirements.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/1b36ca2a-0d3f-4210-a94e-58cf04e23882/69cb6ca4-1f8f-482f-861e-c0e06959ff6f.png"}