On January 7, 2025, the FDA announced crucial draft guidance for AI-driven diagnostics in medical technology, marking a significant shift for MedTech startups. This 67-page document emphasizes total product lifecycle oversight, demanding comprehensive management from design to post-market monitoring. Startups must focus on bias and transparency, addressing dataset diversity and producing “model cards” to prevent delays. The guidance introduces a Predetermined Change Control Plan (PCCP) that allows for proactive FDA approval of routine updates, contingent on clear risk assessments. Additionally, heightened cybersecurity requirements emphasize strategies against unique AI threats. Startups should engage the FDA early, invest in robust data pipelines, and embed security in their designs. This guidance not only raises compliance expectations but also increases time-to-market and costs, necessitating swift adaptation. Aligning with these new requirements can offer startups a competitive edge and enhance consumer trust in AI medical devices. For further insights, refer to Forte Group’s resources.
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