What Devicemakers Need to Know about the FDA Pre-submission Process (Part Two)
Manage episode 374949820 series 3504807
Greenlight Guru + Medical Device Entrepreneurs에서 제공하는 콘텐츠입니다. 에피소드, 그래픽, 팟캐스트 설명을 포함한 모든 팟캐스트 콘텐츠는 Greenlight Guru + Medical Device Entrepreneurs 또는 해당 팟캐스트 플랫폼 파트너가 직접 업로드하고 제공합니다. 누군가가 귀하의 허락 없이 귀하의 저작물을 사용하고 있다고 생각되는 경우 여기에 설명된 절차를 따르실 수 있습니다 https://ko.player.fm/legal.
FDA Pre-submissions: They're a hot, timely topic. We had a recent episode on the pre-submission process, but because there is so much to know, we decided to have our expert speaker, Mike Drues, back to make sure our listeners have the information necessary to properly deal with the FDA. Regulatory non-compliance is one of the biggest risks that medical device companies face, and it’s so important to have a good rapport with the FDA and any other relevant regulatory agencies. Mike Drues is the president of Vascular Sciences. He’s an expert on regulatory topics, as he works with all different types of medical device companies in addition to working with the FDA and other regulatory bodies. Some of the topics that we discuss today include: - Why the pre-submission process has become such a hot topic. - The mechanics of the submission process. - The content of the pre-submission meeting and what questions should be answered. - Why you should not have expectations as to how long the process will take. - How early in the pre-development process you should contact the FDA. - Why the majority of submissions are rejected. - How this process can help you get through changes made post-submission.
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350 에피소드