{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F26f4f42b-6cde-4159-af03-ca6761c8672d","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Regulatory Tips & Observations from a Former FDA Reviewer","description":"What are some recent trends and observations in the medical device industry regarding regulatory affairs and strategies? On today\u2019s episode, we have Allison Komiyama of Acknowledge Regulatory Strategies. She shares her perspective on them, especially as a former FDA reviewer, current consultant who helps companies with regulatory strategies and submissions, and patient of life-saving medical devices.\n \nSome of the highlights of the show include:\n \n\u25cf\tThe regulatory path to get devices approved has been under scrutiny for decades. Companies may think it\u2019s too hard or cut corners with FDA regulations. \n\u25cf\tGet a second opinion, conduct research, and ask questions about medical devices because your or your loved one\u2019s life may depend on the device.\n\u25cf\tFDA reviewers may go into industry because they know how to regulate devices. They understand why regulations are in place to make devices safe, effective.\n\u25cf\tIf a company does testing, gives the FDA what it needs, and participates in the pre-submission process, the likelihood of a device being approved is greater.\n\u25cf\tWhen preparing regulatory documents, review information available on the FDA\u2019s Website and contact DICE and/or regulatory consultant.\n\u25cf\tConsider pre-submission if your company isn\u2019t confident about testing needed or is an early startup that needs guidance on its regulator strategy.\n\u25cf\tAI Letter: Puts your device submission on hold for issues and deficiencies that need to be addressed within 180 days. Avoid getting an NSE letter!\n\u25cf\tUpdate your 510(k) summary if a predicate device has been subject to a recall. FDA wants to make sure the new device does not have the same issues.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/00462cbc-eae1-41d9-9917-a61c5cc29d7f/612b9e42-81f5-4240-af96-6c089687e3e0.jpg"}