buscar

Technology Update
Our present is the best guarantee for the future

New healthcare material coding system in USA

25/08/2014



The FDA (Federal Drugs Administration) has regulated the coding of medical devices in the USA, creating a unique identifier for each article, known as the UDI (Unique Device Identification). A centralized database called GUDID (Global Unique Device Identifier Database) will record all the medical material referenced by the UID.


WHAT IS THE UDI?

THE UDI is the unique identifier for each item, and consists of two parts:
    - DI (Device Identifier): Set part for each article
    - PI (Production Identifier): Variable part for each item, which may contain expiration dates, batch or lot number, SSCC, etc.

WHAT IS THE GUDID?

The GUDID is the database where all medical supplies and medicines are recorded, indexed by UDI. It will include the basic information on the item, such as description, contraindications, dosage, etc.

This database is maintained by the Food and Drug Administration (FDA). Manufacturers must supply the GUDID with the information on their articles, and they will have three ways to do so:
- Through the web provided free of charge by the FDA
- Via the web-service providing integration based on HL7 files (XML defined in USA for the health sector)
- Through GDSN with a specific extension for the purpose.

START-UP TERMS

The FDA has set out different dates by which the different medical articles must be encoded with the pertinent UDI, depending on the article type. 
- 1 year after publication of the final ruling (September 24, 2014)
- 2 years after publication of the final ruling (September 24, 2015)
- 3 years after publication of the final ruling (September 24, 2016)
- 5 years after publication of the final ruling (September 24, 2018)
- 7 years after publication of the final ruling (September 24, 2020)

There are three types of medical supplies, according to the level of controls to be applied by the FDA to ensure the safety and effectiveness of each medical item.

You can access the classification of medical items via the following link: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm

Find out the product classifications as indicated on the FDA website: http://www.fda.gov/%20MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm

 

Would you like to find out more?


Ask for information.

Tags

Cloud Computing B2B Cloud Platform EDI ASP-SaaS e-Invoicing GDSN VMI VAN OFTP2 AS2 Certification Authority Digital Signature Outsourcing SLA Software EDICOM Events Expert Chat SaaS-ASP Corporate Information GS1 CFDI PAC APP Associated Facturae Data Sync NOM151 partners EDICOM Retail public administrations Acreditations Web Portal EDI NF-e einvoicing Partner Web Portal SAP EDI Health Edicomdata CRP EBI ei Payroll Portal B2B EDICOMNet edi logistics SAFT-PT Ticket Portal Avaluos business@mail EDI Manufacturers CT-e NFS-e TSD epayrolls factura electronica edi automotive customer support center comprobante de pago CAE e-billing DTE e-awb comprobantes fiscales electrónicos nfc-e eaccounting contabilidad electronica CFE comprobante fiscal electronico compliance eAWB retenciones electronicas xml-cargo peppol edicom air iata e-cargo IVA Cargo-XML EDICOMAir SUNAT Perú SEE Business Mail Payrolls recibos de sueldo EDI Auto b2g eprocurement datapool panama sii PCRDD SII AEAT NHS edi academy comercio exterior EDICOM LTA sat paperless mmog OFTP EDI Web colombia CFDI Nóminas DIAN México SAF-T VAT DESADV ASN Fatture B2B Costa Rica Complemento pagos Chorus Pro moda interoperabilidad Cancelación suministro inmediato de información european union digitalización emisión electrónica openpeppol global einvoicing factura electrónica ecuador automotive industry United States and Mexico edicom sii norway VAT compliance tax administration air freight sector UNCTAD aviso de expedición Advanced Shipped Notice Despatch Advice data synchronization peppol network peppol standards peppol european union chile tendencias interoperability interconexión SINTEL Brasil interoperabilidade foreign trade e-procurement trends digitization digital transformation SaaS edicomsii MMOG/LE latam global einvociing cybersecurity EDI financeiro white paper factura electrónica colombia fintech fashion eIDAS e-archiving ebimap SME EDICOMLta e-commerce EDI financiero russia fattura b2b B2B e-Invoicing GDPR RTIR FACe FACeB2B portugal blockchain

Follow us on

  • linkedin
  • rss