/**
* Comprehensive FDA field definitions for all search types
* Ported from original implementation to ensure exact field compatibility
*/
import { FdaSearchType } from '../types/fda.js';
export interface FieldValidator {
validateField(field: string, searchType: FdaSearchType): boolean;
getValidFields(searchType: FdaSearchType): string[];
}
export class FdaFieldValidator implements FieldValidator {
/**
* Validate if a field is valid for the given search type
*/
validateField(field: string, searchType: FdaSearchType = 'general'): boolean {
if (!field) return true; // null/undefined is valid (means no field specified)
const validFields = this.getValidFields(searchType);
return validFields.includes(field);
}
/**
* Get list of valid FDA database fields by search type
*/
getValidFields(searchType: FdaSearchType = 'general'): string[] {
switch (searchType) {
case 'adverse_events':
return this.getAdverseEventsFields();
case 'label':
return this.getDrugLabelFields();
case 'recalls':
return this.getRecallsFields();
case 'shortages':
return this.getShortagesFields();
case 'device_registration':
return this.getDeviceRegistrationFields();
case 'device_pma':
return this.getPMAFields();
case 'device_510k':
return this.get510kFields();
case 'device_udi':
return this.getUDIFields();
case 'device_recalls':
return this.getDeviceRecallsFields();
case 'device_adverse_events':
return this.getDeviceAdverseEventsFields();
case 'device_classification':
return this.getDeviceClassificationFields();
case 'substance':
return this.getSubstanceFields();
default:
return this.getDrugsFDAFields();
}
}
/**
* Get fields for drugsfda.json endpoint (general search)
*/
private getDrugsFDAFields(): string[] {
return [
// top-level fields
'application_number',
'sponsor_name',
// openfda section fields
'openfda.application_number',
'openfda.brand_name',
'openfda.generic_name',
'openfda.manufacturer_name',
'openfda.nui',
'openfda.package_ndc',
'openfda.pharm_class_cs',
'openfda.pharm_class_epc',
'openfda.pharm_class_pe',
'openfda.pharm_class_moa',
'openfda.product_ndc',
'openfda.product_type',
'openfda.route',
'openfda.rxcui',
'openfda.spl_id',
'openfda.spl_set_id',
'openfda.substance_name',
'openfda.unii',
'openfda.upc',
'openfda.dosage_form',
'openfda.is_original_packager',
'openfda.original_packager_product_ndc',
// products section fields
'products.active_ingredients.name',
'products.active_ingredients.strength',
'products.brand_name',
'products.dosage_form',
'products.marketing_status',
'products.product_number',
'products.reference_drug',
'products.reference_standard',
'products.route',
'products.te_code',
// submissions section fields
'submissions.application_docs.date',
'submissions.application_docs.type',
'submissions.application_docs.url',
'submissions.review_priority',
'submissions.submission_class_code',
'submissions.submission_class_code_description',
'submissions.submission_number',
'submissions.submission_property_type.code',
'submissions.submission_public_notes',
'submissions.submission_status',
'submissions.submission_status_date',
'submissions.submission_type'
];
}
/**
* Get fields for event.json endpoint (adverse events)
*/
private getAdverseEventsFields(): string[] {
return [
// Fields with empty sections (root level)
'authoritynumb',
'companynumb',
'duplicate',
'fulfillexpeditecriteria',
'occurcountry',
'receiptdate',
'receiptdateformat',
'receivedate',
'receivedateformat',
'reporttype',
'safetyreportid',
'safetyreportversion',
'serious',
'seriousnesscongenitalanomali',
'seriousnessdeath',
'seriousnessdisabling',
'seriousnesshospitalization',
'seriousnesslifethreatening',
'seriousnessother',
'transmissiondate',
'transmissiondateformat',
// patient.drug section fields
'patient.drug.actiondrug',
'patient.drug.activesubstance.activesubstancename',
'patient.drug.drugadditional',
'patient.drug.drugauthorizationnumb',
'patient.drug.drugbatchnumb',
'patient.drug.drugcharacterization',
'patient.drug.drugcumulativedosagenumb',
'patient.drug.drugcumulativedosageunit',
'patient.drug.drugdosagetext',
'patient.drug.drugenddate',
'patient.drug.drugenddateformat',
'patient.drug.drugindication',
'patient.drug.drugintervaldosagedefinition',
'patient.drug.drugintervaldosageunitnumb',
'patient.drug.medicinalproduct',
'patient.drug.drugrecurreadministration',
'patient.drug.drugrecurrence',
'patient.drug.drugseparatedosagenumb',
'patient.drug.drugstartdate',
'patient.drug.drugstartdateformat',
'patient.drug.drugstructuredosagenumb',
'patient.drug.drugstructuredosageunit',
'patient.drug.drugtreatmentduration',
'patient.drug.drugtreatmentdurationunit',
// patient section fields
'patient.patientagegroup',
'patient.patientdeath.patientdeathdate',
'patient.patientdeath.patientdeathdateformat',
'patient.patientonsetage',
'patient.patientonsetageunit',
'patient.patientsex',
'patient.patientweight',
// patient.reaction section fields
'patient.reaction.reactionmeddrapt',
'patient.reaction.reactionmeddraversionpt',
'patient.reaction.reactionoutcome',
// patient.summary section fields
'patient.summary.narrativeincludeclinical',
// primarysource section fields
'primarysource.literaturereference',
'primarysource.qualification',
'primarysource.reportercountry',
'primarysource.primarysourcecountry',
// receiver section fields
'receiver.receiverorganization',
'receiver.receivertype',
// reportduplicate section fields
'reportduplicate.duplicatenumb',
'reportduplicate.duplicatesource',
// sender section fields
'sender.senderorganization',
'sender.sendertype'
];
}
/**
* Get fields for label.json endpoint
*/
private getDrugLabelFields(): string[] {
return [
'effective_time',
'inactive_ingredient',
'spl_product_data_elements',
'purpose',
'version',
'ask_doctor',
'ask_doctor_or_pharmacist',
'do_not_use',
'openfda.application_number',
'openfda.brand_name',
'openfda.generic_name',
'openfda.manufacturer_name',
'openfda.product_ndc',
'openfda.product_type',
'openfda.route',
'openfda.substance_name',
'openfda.rxcui',
'openfda.spl_id',
'openfda.spl_set_id',
'openfda.package_ndc',
'openfda.nui',
'openfda.pharm_class_epc',
'openfda.pharm_class_pe',
'openfda.pharm_class_moa',
'openfda.pharm_class_cs',
'openfda.unii',
'warnings',
'indications_and_usage',
'dosage_and_administration',
'dosage_forms_and_strengths',
'contraindications',
'warnings_and_cautions',
'adverse_reactions',
'drug_interactions',
'use_in_specific_populations',
'drug_abuse_and_dependence',
'overdosage',
'description',
'clinical_pharmacology',
'nonclinical_toxicology',
'clinical_studies',
'references',
'how_supplied',
'storage_and_handling',
'patient_counseling_information',
'boxed_warning',
'recent_major_changes',
'brand_name_base',
'generic_name_base',
'labeler_name',
'product_id',
'product_ndc',
'application_number',
'sponsor_name',
'fullname',
'appl_type',
'appl_no',
'product_no',
'te_code',
'approval_date',
'rld',
'type',
'applicant',
'strength',
'df_route',
'trade_name',
'applicant_full_name',
'dosage_form',
'marketing_status',
'chemical_name',
'active_ingredient',
'drug_name',
'manufacturer_name',
'pharm_class',
'indication_class',
'schedule',
'nda_number',
'application_type',
'submission_type',
'submission_number',
'submission_status',
'submission_status_date',
'marketing_category',
'dosage_form_name',
'route_name',
'marketing_category_name',
'pharm_class_epc',
'pharm_class_pe',
'pharm_class_moa',
'pharm_class_cs',
'dea_schedule',
'listing_expiration_date',
'openfda.is_original_packager',
'openfda.upc',
'set_id',
'id',
'spl_version',
'document_type',
'effective_date',
'version_number',
'pregnancy_or_breast_feeding',
'geriatric_use',
'pediatric_use',
'animal_pharmacology_and_or_toxicology',
'controlled_substance',
'abuse',
'dependence',
'carcinogenesis_and_mutagenesis_and_impairment_of_fertility',
'pregnancy',
'labor_and_delivery',
'nursing_mothers',
'information_for_patients',
'laboratory_tests',
'carcinogenesis_mutagenesis_impairment_of_fertility',
'teratogenic_effects',
'nonteratogenic_effects',
'labor_delivery',
'nursing_mothers_subsection',
'pediatric_use_subsection',
'geriatric_use_subsection',
'hepatic_impairment',
'renal_impairment',
'female_and_male_of_reproductive_potential',
'lactation',
'females_and_males_of_reproductive_potential',
'pediatric_patients',
'geriatric_patients',
'hepatic_impairment_subsection',
'renal_impairment_subsection',
'immunocompromised_patients',
'race_ethnicity',
'keep_out_of_reach_of_children',
'questions',
'package_label_principal_display_panel',
'spl_medguide',
'spl_patient_package_insert',
'information_for_the_patient',
'instructions_for_use',
'medication_guide',
'user_safety_warnings',
'precautions',
'when_using',
'stop_use',
'pregnancy_breast_feeding',
'keep_out_of_reach',
'directions',
'other_information',
'principal_display_panel',
'active_ingredient_section',
'inactive_ingredient_section',
'warnings_section',
'when_using_section',
'stop_use_section',
'directions_section',
'other_information_section',
'questions_section',
'package_label_section',
'carton_labeling',
'container_labeling',
'blister_pack_labeling',
'bottle_labeling',
'tube_labeling',
'pouch_labeling',
'syringe_labeling',
'vial_labeling',
'ampule_labeling',
'prefilled_syringe_labeling'
];
}
/**
* Get fields for enforcement.json endpoint (recalls)
*/
private getRecallsFields(): string[] {
return [
// Recall Information
'recalling_firm',
'classification',
'status',
'reason_for_recall',
'product_type',
'voluntary_mandated',
// Product Details
'product_description',
'code_info',
'more_code_info',
'product_quantity',
'distribution_pattern',
// Timeline
'report_date',
'recall_initiation_date',
'center_classification_date',
'termination_date',
'initial_firm_notification',
// Tracking
'recall_number',
'event_id',
// Geographic and Address
'address_1',
'address_2',
'city',
'state',
'country',
'postal_code',
// OpenFDA fields
'openfda.application_number',
'openfda.brand_name',
'openfda.generic_name',
'openfda.manufacturer_name',
'openfda.nui',
'openfda.package_ndc',
'openfda.pharm_class_cs',
'openfda.pharm_class_epc',
'openfda.pharm_class_pe',
'openfda.pharm_class_moa',
'openfda.product_ndc',
'openfda.route',
'openfda.rxcui',
'openfda.spl_id',
'openfda.spl_set_id',
'openfda.substance_name',
'openfda.unii',
'openfda.upc'
];
}
/**
* Get fields for shortages.json endpoint
*/
private getShortagesFields(): string[] {
return [
// Product Information
'package_ndc',
'generic_name',
'proprietary_name',
'company_name',
'product_id',
'presentation',
// Shortage Details
'status',
'availability',
'shortage_reason',
'therapeutic_category',
'resolved_note',
// Timeline
'update_date',
'change_date',
'discontinued_date',
'initial_posting_date',
'update_type',
// Contact & Links
'contact_info',
'related_info',
'related_info_link',
// Technical
'dosage_form',
'strength',
// OpenFDA fields
'openfda.application_number',
'openfda.brand_name',
'openfda.dosage_form',
'openfda.generic_name',
'openfda.is_original_packager',
'openfda.manufacturer_name',
'openfda.nui',
'openfda.original_packager_product_ndc',
'openfda.package_ndc',
'openfda.pharm_class_cs',
'openfda.pharm_class_epc',
'openfda.pharm_class_moa',
'openfda.pharm_class_pe',
'openfda.product_ndc',
'openfda.product_type',
'openfda.route',
'openfda.rxcui',
'openfda.spl_id',
'openfda.spl_set_id',
'openfda.substance_name',
'openfda.unii',
'openfda.upc'
];
}
/**
* Get fields for device/registrationlisting.json endpoint
*/
private getDeviceRegistrationFields(): string[] {
return [
// Device Info
'proprietary_name',
'establishment_type',
'pma_number',
'k_number',
// Registration Info
'registration.registration_number',
'registration.fei_number',
'registration.status_code',
'registration.initial_importer_flag',
'registration.reg_expiry_date_year',
'registration.name',
'registration.address_line_1',
'registration.address_line_2',
'registration.city',
'registration.state_code',
'registration.iso_country_code',
'registration.zip_code',
'registration.postal_code',
// US Agent Info
'registration.us_agent.name',
'registration.us_agent.business_name',
'registration.us_agent.bus_phone_area_code',
'registration.us_agent.bus_phone_num',
'registration.us_agent.bus_phone_extn',
'registration.us_agent.fax_area_code',
'registration.us_agent.fax_num',
'registration.us_agent.email_address',
'registration.us_agent.address_line_1',
'registration.us_agent.address_line_2',
'registration.us_agent.city',
'registration.us_agent.state_code',
'registration.us_agent.iso_country_code',
'registration.us_agent.zip_code',
'registration.us_agent.postal_code',
// Owner Operator Info
'registration.owner_operator.firm_name',
'registration.owner_operator.owner_operator_number',
'registration.owner_operator.contact_address.address_1',
'registration.owner_operator.contact_address.address_2',
'registration.owner_operator.contact_address.city',
'registration.owner_operator.contact_address.state_code',
'registration.owner_operator.contact_address.state_province',
'registration.owner_operator.contact_address.iso_country_code',
'registration.owner_operator.contact_address.postal_code',
// Products Info
'products.product_code',
'products.created_date',
'products.owner_operator_number',
'products.exempt',
// OpenFDA Products Section
'products.openfda.k_number',
'products.openfda.device_name',
'products.openfda.medical_specialty_description',
'products.openfda.regulation_number',
'products.openfda.device_class'
];
}
/**
* Get fields for device/pma.json endpoint (Pre-Market Approval)
*/
private getPMAFields(): string[] {
return [
// Application Info
'pma_number',
'supplement_number',
'supplement_type',
'supplement_reason',
'expedited_review_flag',
// Company Info
'applicant',
'street_1',
'street_2',
'city',
'state',
'zip',
'zip_ext',
// Device Info
'generic_name',
'trade_name',
'product_code',
'advisory_committee',
'advisory_committee_description',
// Timeline
'date_received',
'decision_date',
'docket_number',
// Decision
'decision_code',
'ao_statement',
// OpenFDA fields
'openfda.registration_number',
'openfda.fei_number',
'openfda.device_name',
'openfda.medical_specialty_description',
'openfda.regulation_number',
'openfda.device_class'
];
}
/**
* Get fields for device/510k.json endpoint (510(k) Clearances)
*/
private get510kFields(): string[] {
return [
// Application Info
'k_number',
'third_party_flag',
'statement_or_summary',
'clearance_type',
'expedited_review_flag',
// Company Info
'applicant',
'address_1',
'address_2',
'city',
'state',
'zip_code',
'postal_code',
'country_code',
'contact',
// Device Info
'device_name',
'product_code',
'advisory_committee',
'advisory_committee_description',
'review_advisory_committee',
// Timeline
'date_received',
'decision_date',
'decision_code',
'decision_description',
// OpenFDA fields
'openfda.registration_number',
'openfda.fei_number',
'openfda.device_name',
'openfda.medical_specialty_description',
'openfda.regulation_number',
'openfda.device_class'
];
}
/**
* Get fields for device/udi.json endpoint (Unique Device Identifier)
*/
private getUDIFields(): string[] {
return [
// Device Information
'device_description',
'brand_name',
'company_name',
'version_or_model_number',
'catalog_number',
// Status and Record Info
'public_device_record_key',
'public_version_status',
'record_status',
'commercial_distribution_status',
'public_version_date',
'public_version_number',
'publish_date',
// Device Properties
'is_rx',
'is_otc',
'is_single_use',
'is_combination_product',
'is_kit',
'has_serial_number',
'has_manufacturing_date',
'has_lot_or_batch_number',
'has_expiration_date',
'has_donation_id_number',
'is_labeled_as_nrl',
'is_labeled_as_no_nrl',
'is_direct_marking_exempt',
'is_pm_exempt',
'is_hct_p',
'device_count_in_base_package',
// Safety Information
'mri_safety',
'sterilization.is_sterile',
'sterilization.is_sterilization_prior_use',
'sterilization.sterilization_methods',
// Product Classification
'product_codes.code',
'product_codes.name',
'product_codes.openfda.device_name',
'product_codes.openfda.medical_specialty_description',
'product_codes.openfda.regulation_number',
'product_codes.openfda.device_class',
// GMDN Terms
'gmdn_terms.code',
'gmdn_terms.name',
'gmdn_terms.definition',
'gmdn_terms.implantable',
'gmdn_terms.code_status',
// Identifiers
'identifiers.id',
'identifiers.type',
'identifiers.issuing_agency',
'labeler_duns_number',
// Contact Information
'customer_contacts.phone',
'customer_contacts.email'
];
}
/**
* Get fields for device/enforcement.json endpoint (Device Recalls)
*/
private getDeviceRecallsFields(): string[] {
return [
// Recall Classification and Status
'classification',
'status',
'product_type',
// Company and Location Info
'recalling_firm',
'city',
'state',
'country',
'address_1',
'address_2',
'postal_code',
// Recall Details
'voluntary_mandated',
'initial_firm_notification',
'reason_for_recall',
// Product Information
'product_description',
'product_quantity',
'code_info',
'more_code_info',
// Timeline
'report_date',
'recall_initiation_date',
'center_classification_date',
// Distribution and Tracking
'distribution_pattern',
'recall_number',
'event_id',
// OpenFDA fields
'openfda.device_name',
'openfda.device_class',
'openfda.regulation_number',
'openfda.medical_specialty_description',
'openfda.product_code',
'openfda.registration_number',
'openfda.fei_number'
];
}
/**
* Get fields for device/event.json endpoint (Device Adverse Events)
*/
private getDeviceAdverseEventsFields(): string[] {
return [
// Report Timeline and Metadata
'date_received',
'date_report',
'date_of_event',
'date_facility_aware',
'date_report_to_fda',
'date_added',
'date_changed',
// Report Details
'event_type',
'report_number',
'type_of_report',
'report_source_code',
'adverse_event_flag',
'product_problem_flag',
'event_location',
'health_professional',
'initial_report_to_fda',
'report_to_fda',
'report_to_manufacturer',
'mdr_report_key',
'single_use_flag',
'previous_use_code',
'remedial_action',
'removal_correction_number',
'number_devices_in_event',
'number_patients_in_event',
'summary_report_flag',
// Manufacturer Information
'manufacturer_name',
'manufacturer_address_1',
'manufacturer_address_2',
'manufacturer_city',
'manufacturer_state',
'manufacturer_zip_code',
'manufacturer_country',
'manufacturer_postal_code',
'manufacturer_contact_f_name',
'manufacturer_contact_l_name',
'manufacturer_contact_t_name',
'manufacturer_contact_phone_number',
'manufacturer_contact_extension',
'manufacturer_contact_area_code',
'manufacturer_contact_city',
'manufacturer_contact_state',
'manufacturer_contact_zip_code',
'manufacturer_contact_country',
'manufacturer_link_flag',
// Device Information (nested fields)
'device.brand_name',
'device.generic_name',
'device.manufacturer_d_name',
'device.manufacturer_d_city',
'device.manufacturer_d_state',
'device.manufacturer_d_country',
'device.model_number',
'device.catalog_number',
'device.lot_number',
'device.other_id_number',
'device.device_report_product_code',
'device.device_operator',
'device.device_availability',
'device.implant_flag',
'device.device_age_text',
'device.device_evaluated_by_manufacturer',
'device.date_removed_flag',
'device.baseline_510_k__flag',
'device.baseline_510_k__number',
'device.baseline_510_k__exempt_flag',
// OpenFDA Device Fields
'device.openfda.device_name',
'device.openfda.medical_specialty_description',
'device.openfda.regulation_number',
'device.openfda.device_class',
// Patient Information (nested fields)
'patient.patient_age',
'patient.patient_sex',
'patient.patient_weight',
'patient.patient_ethnicity',
'patient.patient_race',
'patient.sequence_number_treatment',
'patient.sequence_number_outcome',
// MDR Text Information (nested fields)
'mdr_text.text_type_code',
'mdr_text.text',
// Distributor Information
'distributor_name',
'distributor_address_1',
'distributor_address_2',
'distributor_city',
'distributor_state',
'distributor_zip_code',
'distributor_zip_code_ext',
// Additional Fields
'pma_pmn_number',
'exemption_number',
'reporter_occupation_code',
'reporter_country_code',
'reprocessed_and_reused_flag'
];
}
/**
* Get fields for device/classification.json endpoint (Device Classification)
*/
private getDeviceClassificationFields(): string[] {
return [
// Basic Device Information
'product_code',
'device_name',
'device_class',
'regulation_number',
// Medical Specialty Information
'medical_specialty',
'medical_specialty_description',
'review_panel',
// Classification Details
'definition',
'unclassified_reason',
'review_code',
'submission_type_id',
// Device Flags
'implant_flag',
'life_sustain_support_flag',
'gmp_exempt_flag',
'third_party_flag',
// Reporting Information
'summary_malfunction_reporting',
// OpenFDA Fields
'openfda.k_number',
'openfda.registration_number',
'openfda.fei_number'
];
}
/**
* Get fields for substance.json endpoint (Substance/UNII data)
*/
private getSubstanceFields(): string[] {
return [
// Core substance identification
'unii',
'substance_name',
// Codes and identifiers
'codes.code',
'codes.type',
'codes.code_system',
'codes.url',
// Relationships (including active moiety, targets, inhibitors)
'relationships.type',
'relationships.qualification',
'relationships.related_substance.name',
'relationships.related_substance.unii',
'relationships.amount.average',
'relationships.amount.units',
// Names and synonyms
'names.name',
'names.type',
// Properties
'properties.name',
'properties.value',
// Structure
'structure.molecular_formula',
'structure.molecular_weight',
'structure.smiles',
// Modifications
'modifications.agent_modifications',
'modifications.structural_modifications',
// References
'references.citation',
'references.doc_type'
];
}
}
// Create singleton instance
export const fieldValidator = new FdaFieldValidator();
// Export validation utilities
export function validateFieldForSearchType(field: string, searchType: FdaSearchType): boolean {
return fieldValidator.validateField(field, searchType);
}
export function getValidFieldsForSearchType(searchType: FdaSearchType): string[] {
return fieldValidator.getValidFields(searchType);
}
