{"id":92409,"topic":"ai","source":"Cooley","title":"Regulating AI Like a Doctor: FDA Floats Competency-Based Path for Generative AI-Enabled Devices - Cooley","url":"https://www.cooley.com/news/insight/2026/2026-09-28-regulating-ai-like-a-doctor-fda-floats-competency-based-path-for-generative-ai-enabled-devices","url_hash":"6535964fca702cfc533e3ab4b66825b67c88d1ac","author":"","summary":"<a href=\"https://news.google.com/rss/articles/CBMi3wFBVV95cUxPQWlGeENrTzItSk9OZjdWTXoyYjFyOGNDWUZVNWNycjVPLVFsU2l1Wno0YXdIZWp3X0xsR1g2eGZ4X01rRWl6a1dBZ25jR2JjWnlFdHF6ZEtuY3hJUTZQaWV5Z1Ftc3k2ZllENUM5amFMWWtrdTctdjhjUmFYVmdIa2ZfeUFIalREblA2VzdBUnRFeWhDaHVFcFNXMUZrckFzd3lEbDJERjZtaDlxTTZhTzVxSG9CTlk4ZXNoRFF4eHNaSk9aMWxESVAtd0pfRkNib2ZZblFVcVZBUC10Q2M0?oc=5\" target=\"_blank\">Regulating AI Like a Doctor: FDA Floats Competency-Based Path for Generative AI-Enabled Devices</a>&nbsp;&nbsp;<font color=\"#6f6f6f\">Cooley</font>","content":null,"image_url":null,"lang":"en","published_at":"2026-09-28T20:35:08+00:00","fetched_at":"2026-09-29T03:15:05+00:00","status":"read","starred":0,"extract_state":"failed","summary_auto":null,"cluster_id":3505312,"extract_retries":2,"extract_error":"trafilatura_none","contract_version":"news_item.v1","format_contract_version":"news_item_formats.v1","dedup_url":"https://www.cooley.com/news/insight/2026/2026-09-28-regulating-ai-like-a-doctor-fda-floats-competency-based-path-for-generative-ai-enabled-devices","quality_profile":{"profile_version":"extraction_quality.v2","bucket":"low","confidence":0.2,"failure_kind":"extractor_empty","retryable":false,"retry_after_attempts":0,"reason":"Low confidence: extractor returned no usable article text.","operator_guidance":{"severity":"warning","recommended_action":"use_summary_with_caveat","next_step":"Use the available summary only with a visible quality caveat.","operator_label":"Use summary with caveat","can_retry":false,"can_use_summary":true,"diagnostics_required":true},"content_depth":{"contract_version":"content_depth.v1","category":"summary_only","label":"Summary only","has_full_text":false,"has_summary":true,"content_length":0,"summary_length":519,"usable_text_length":519,"source_field":"summary"},"legacy_collapsed":false,"signals":{"extract_state":"failed","extract_error":"trafilatura_none","extract_retries":2,"content_length":0,"summary_length":519}},"news_item":{"id":92409,"canonical_url":"https://www.cooley.com/news/insight/2026/2026-09-28-regulating-ai-like-a-doctor-fda-floats-competency-based-path-for-generative-ai-enabled-devices","source_url":"https://www.cooley.com/news/insight/2026/2026-09-28-regulating-ai-like-a-doctor-fda-floats-competency-based-path-for-generative-ai-enabled-devices","title":"Regulating AI Like a Doctor: FDA Floats Competency-Based Path for Generative AI-Enabled Devices - 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