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7 ways to challenge FDA’s regulation of LDTs
Manage episode 405521517 series 3506216
Darshan Kulkarni에서 제공하는 콘텐츠입니다. 에피소드, 그래픽, 팟캐스트 설명을 포함한 모든 팟캐스트 콘텐츠는 Darshan Kulkarni 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.
The FDA's announcement of its intention to regulate Lab Developed Tests (LDTs) in line with medical device regulations has sparked concerns among developers, anticipating significant financial implications.
We provide a comprehensive overview of seven strategic approaches for LDT developers to challenge the FDA's regulatory proposal.
Firstly, leveraging the public comment period,
Participating in Part 15 hearings provide direct avenues to voice concerns and influence final regulations,
Additionally, joining industry associations allows for collective lobbying efforts on behalf of developers,
Exploring legal challenges, though potentially premature without final action, remains an option,
Raising public awareness through media campaigns is suggested, emphasizing the benefits of LDTs and drawbacks of proposed regulations.
Collaboration with healthcare providers to gather real-world evidence and testimonials strengthens the developers' case.
Lastly, engaging in congressional lobbying harnesses legislative power to potentially alter or block the FDA's proposals.
Despite the FDA's focus on patient safety, developers are presented with a multi-pronged approach to effectively challenge and shape the outcome of the regulatory process.
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