{"id":"7db23559-9b6f-43a7-a6bb-476456cd3316","slug":"fda-ai-enabled-device-guidance-2025","kind":"safety_standard","headline":"FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management","summary":"FDA issued comprehensive draft guidance for AI-enabled medical devices covering total product lifecycle (TPLC) management, including design controls, data governance, transparency, bias mitigation, validation, and post-market monitoring. Guidance recommends predetermining AI model changes via Predetermined Change Control Plans (PCCPs).","locationId":"aa8b9c05-c836-4021-801f-59801970401e","effectiveAt":"2025-01-06T00:00:00.000Z","expiresAt":null,"reviewStatus":"unreviewed","formFactors":["surgical","biometric","wearable"],"jurisdiction":"US Federal","complianceDeadline":null,"enforcementEvents":null,"aliases":[],"collisionRisk":"none","reviewNote":null,"createdAt":"2026-08-09T14:31:31.048Z","updatedAt":"2026-08-09T14:31:31.048Z","location":{"id":"aa8b9c05-c836-4021-801f-59801970401e","name":"United States","slug":"united-states","kind":"country","parentLocationId":null,"region":null,"lat":37.0902,"lng":-95.7129,"reviewStatus":"reviewed","aliases":["USA","US","United States of America","united-states-usa","United States"],"collisionRisk":"high","reviewNote":null,"createdAt":"2026-05-30T22:00:33.148Z","updatedAt":"2026-08-09T01:55:18.164Z"},"derived":{"status":"in_effect"},"sources":[{"id":"09bbc6b1-cf05-4040-99a9-77cf86e36fec","regulationId":"7db23559-9b6f-43a7-a6bb-476456cd3316","url":"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/artificial-intelligence-enabled-device-software-functions-lifecycle-management-and-marketing","label":null,"publishedAt":"2025-01-06T00:00:00.000Z","notes":null,"title":"Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations","sourceName":"FDA","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-08-09T14:31:31.048Z","updatedAt":"2026-08-09T14:31:31.048Z"}],"statusEvents":[{"id":"6c794be8-4816-42bc-b78e-fc475eb3380e","regulationId":"7db23559-9b6f-43a7-a6bb-476456cd3316","status":"in_effect","reason":"Initial ingestion","source":"agent-recon","effectiveAt":"2025-01-06T00:00:00.000Z","createdAt":"2026-08-09T14:31:31.048Z"}],"jsonLd":{"@context":"https://schema.org","@type":"Legislation","@id":"https://registry.deploy.report/regulations/fda-ai-enabled-device-guidance-2025","url":"https://registry.deploy.report/regulations/fda-ai-enabled-device-guidance-2025","name":"FDA Draft Guidance: AI-Enabled Device Software Functions Lifecycle Management","description":"FDA issued comprehensive draft guidance for AI-enabled medical devices covering total product lifecycle (TPLC) management, including design controls, data governance, transparency, bias mitigation, validation, and post-market monitoring. Guidance recommends predetermining AI model changes via Predetermined Change Control Plans (PCCPs).","identifier":"7db23559-9b6f-43a7-a6bb-476456cd3316","legislationDate":"2025-01-06T00:00:00.000Z","legislationApplies":{"@type":"Place","name":"United States"},"publisher":{"@id":"https://deploy.report/#organization"}},"framework_metadata":{"framework_schema_version":"0.1.0","verification_status":"unreviewed","maturity_stage":null,"lifecycle_state":null,"architectural_position":{"cohort":null,"sub_cohorts":[]},"within_cohort_verified_vs_claimed_pair":null,"cap_flags":[],"verification_depth":{"sources_count":1,"primary_source_types":["primary-fda-database"]}}}