/**
 * FDA Software Pre-Cert + SaMD TPLC + AI/ML Action Plan Compliance Pack
 *
 * The FDA Software Pre-Certification (Pre-Cert) Pilot Program (2017–2022,
 * transitioned to ongoing program elements) was an alternative regulatory
 * pathway for SaMD developers. Instead of FDA reviewing every product
 * release, qualified developers earn organizational pre-certification by
 * demonstrating "Excellence" in five domains:
 *
 *   1. Patient Safety
 *   2. Product Quality
 *   3. Clinical Responsibility
 *   4. Cybersecurity Responsibility
 *   5. Proactive Culture
 *
 * Once pre-certified, releases follow streamlined review pathways with
 * continuous post-market real-world performance monitoring. The pilot ended
 * formally in 2022 but its principles inform FDA's current Pre-Submission
 * program, Total Product Lifecycle (TPLC) approach, and the FDA AI/ML SaMD
 * Action Plan. Key ongoing mechanisms:
 *
 *   - Pre-Submission (Q-Sub) program — organizational excellence assessment
 *   - TPLC approach — lifecycle-based regulatory oversight
 *   - FDA AI/ML SaMD Action Plan (Jan 2021) — 5-part roadmap for adaptive AI
 *   - Pre-Determined Change Control Plan (PCCP) — FDA's formalized change
 *     management approach for AI/ML (guidance finalized 2024)
 *   - Algorithm Change Protocol (ACP) — pre-cleared bounded changes for AI/ML
 *
 * SaMD Definition (IMDRF SaMD: Key Definitions N10, 2013):
 *   Software intended to be used for one or more medical purposes that
 *   performs those purposes without being part of a hardware medical device.
 *
 * IMDRF SaMD Risk Categorization (N12, 2014):
 *   Four categories based on state of healthcare situation × significance
 *   of information provided by the SaMD to healthcare decision:
 *     Category I  — Non-serious + inform clinical management
 *     Category II — Serious + inform clinical management OR
 *                   Non-serious + drive clinical management
 *     Category III — Critical + inform clinical management OR
 *                    Serious + drive clinical management OR
 *                    Non-serious + treat/diagnose
 *     Category IV  — Critical + drive or treat/diagnose
 *
 * Customer base: clinical decision support vendors, AI/ML diagnostic
 * developers, digital therapeutics, remote patient monitoring software
 * vendors, EHR-integrated software publishers, continuous glucose monitors,
 * dermatology AI, radiology AI, cardiology AI, mental health app developers.
 *
 * Key regulatory citations:
 *   21 CFR Part 803  — Medical Device Reporting (MDR): 5-day + 30-day windows
 *   21 CFR Part 806  — Reports of Corrections and Removals
 *   21 CFR Part 820  — Quality System Regulation / QMSR (eff. Feb 2026)
 *   21 CFR Part 822  — Post-Market Surveillance
 *   21 U.S.C. §360j(o) — PATCH Act §524B (2023): cybersecurity premarket
 *   FDA Guidance: "Predetermined Change Control Plans for Machine Learning-
 *                  Enabled Medical Devices" (2024)
 *   FDA Guidance: "Artificial Intelligence/Machine Learning (AI/ML)-Based
 *                  Software as a Medical Device (SaMD) Action Plan" (2021)
 *   IMDRF SaMD: Clinical Evaluation (N41, 2017)
 *   FDA Guidance: "Cybersecurity in Medical Devices: Quality System
 *                  Considerations and Content of Premarket Submissions" (2023)
 *
 * Retention:
 *   30-year life-of-device baseline (10950 days). Aligns with FDA 21 CFR
 *   820.180 (quality system records retained for expected life of device or
 *   2 years from date of release — SaMD life expectancy commonly 20-30 years
 *   for embedded clinical-workflow integrations). Matches FDA MDR record
 *   retention (21 CFR 803.18 — minimum 2 years; extended for implant-class
 *   SaMD). Conservative 30-year baseline chosen for life-of-device traceability.
 *
 * Incident reporting (21 CFR 803 MDR):
 *   5 days: deaths, serious injuries, or malfunctions likely to cause/contribute
 *   30 days: other reportable events (standard MDR window)
 *   Conservative baseline: 5-day window (120 hours) applies when patient
 *   safety or serious injury is a reasonable possibility.
 *
 * @connexum/ai-governance
 */
import { CompliancePack } from './index';
import { CategoryClassifiers } from '../classification/pack-driven-classifier';
/**
 * FDA SaMD Pre-Cert + TPLC category classifiers.
 *
 * Covers SaMD-specific artefacts:
 *   - PCCP (Pre-Determined Change Control Plan) change records
 *   - ACP (Algorithm Change Protocol) submissions
 *   - Clinical evaluation evidence and intended-use documentation
 *   - Post-market real-world performance signals
 *   - Cybersecurity vulnerability disclosure and SBOM records
 */
export declare const FDA_SAMD_PRECERT_CATEGORY_CLASSIFIERS: CategoryClassifiers;
/**
 * FDA Software Pre-Cert + SaMD TPLC + AI/ML Action Plan Compliance Pack.
 *
 * Pack ID: 'fda-samd-precert'
 * Jurisdiction: United States — FDA CDRH regulatory framework.
 *   Principles inform IMDRF member jurisdictions globally (EU MDR,
 *   Health Canada, TGA, PMDA for AI/ML SaMD).
 *
 * Guard-layer wiring:
 *   - G1-G4 (audit, logging, classification, session): always active
 *   - G5 (supply-chain): always active — PRC provider blocks; SBOM chain
 *   - G6 (approval-queue): always active — PCCP changes; clinical eval; MDR
 *   - G7 (attestation): always active — clinical evaluation officer sign-off;
 *       PCCP change controller attestation; QMS lead attestation
 *   - G8 (anomaly-detector): always active — out-of-PCCP-bounds CRITICAL block;
 *       post-market signal detection; cybersecurity anomaly detection
 *   - G9 (transparency): always active — AI provenance disclosure for SaMD
 *       clinical outputs; TPLC monitoring report provenance
 *
 * Human-in-loop tier:
 *   - T1: Routine QMS records, standard PCCP-bounded changes (qms-lead review)
 *   - T2: Clinical evaluation changes, intended-use scoping changes, PCCP
 *         modifications (clinical-evaluation-officer + fda-liaison sign-off)
 *   - T3: Out-of-PCCP-bounds changes, MDR-reportable events (immediate escalation:
 *         pccp-change-controller + fda-liaison + clinical-evaluation-officer)
 */
export declare const FDA_SAMD_PRECERT_PACK: CompliancePack & {
    categoryClassifiers: CategoryClassifiers;
    subjectKeyedCategories: string[];
};
//# sourceMappingURL=fda-samd-precert.d.ts.map