/**
 * FDA SaMD Compliance Pack
 *
 * FDA Software as a Medical Device (SaMD) for AI/ML systems under
 * the Federal Food, Drug, and Cosmetic Act §201(h) and 21 CFR Parts
 * 807, 820, 821.
 *
 * Standards referenced:
 *   - 21 CFR Part 820 QMSR (Quality Management System Regulation,
 *     effective 2 February 2026; harmonises with ISO 13485:2016)
 *   - 2024 FDA PCCP Guidance (Predetermined Change Control Plan)
 *   - 2024 FDA AI/ML Lifecycle Guidance
 *   - Good Machine Learning Practice Principles (2021 FDA+HC+MHRA)
 *   - 21 CFR Part 803 (Medical Device Reporting / MDR)
 *   - 21 CFR Part 822 (Post-market surveillance)
 *   - PATCH Act §524B (2023 cybersecurity for premarket submissions)
 *   - IMDRF SaMD Risk Categorization Framework (Category I-IV)
 *   - 510(k), De Novo, PMA pathways
 *
 * Current state (2026):
 *   - QMSR effective 2 Feb 2026 -- new SaMD submissions must use
 *     QMSR (ISO 13485:2016 alignment).
 *   - PCCP accepted as formal mechanism for AI/ML model updates.
 *   - GMLP 10 principles are the de facto AI/ML SaMD baseline.
 *   - SBOM mandatory for cybersecurity (PATCH Act).
 *   - Real-world performance monitoring required per 2024 guidance.
 *
 * @connexum/ai-governance
 */
import { CompliancePack } from './index';
import { CategoryClassifiers } from '../classification/pack-driven-classifier';
/**
 * FDA SaMD (Software as a Medical Device) category classifiers.
 * 21 CFR Parts 820 (QMSR) + 830 (UDI) + FDA AI/ML Action Plan.
 * PHI is BLOCK; clinical data and medical imaging are LOG (evidence capture).
 */
export declare const FDA_SAMD_CATEGORY_CLASSIFIERS: CategoryClassifiers;
export declare const FDA_SAMD_PACK: CompliancePack & {
    categoryClassifiers: CategoryClassifiers;
    subjectKeyedCategories: string[];
};
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