#DDOD: Establishment Registration & Device Listing

Metadata Updated: November 10, 2020

SUMMARY DDOD use case to request means on consolidating multiple data sources (MDR, PMA, 510(k), R&L) in order to build a list of all marketed medical devices. WHAT IS A USE CASE? A “Use Case” is a request that was made by the user community because there were no available datasets that met their particular needs. If this use case is similar to your needs, we ask that you add your own requirements to the specifications section. The concept of a use case falls within the Demand-Driven Open Data (DDOD) program and gives you a formalized way to identify what data you need. It’s for anyone in industry, research, media, nonprofits or other government agencies. Each request becomes a DDOD use case, so that it can be prioritized and worked on. Use Cases also provide a wealth of insights about existing alternative datasets and tips for interpreting and manipulating data for specific purposes. PURPOSE The US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has multiple data sources for registered medical devices, including Medical Device Reporting (MDR), Premarket Approval (PMA), 510(k), and Establishment Registration and Device Listing (R&L). There are a number of challenges associated with the data, including:

A single marketed product often has multiple 510(k)s A PMA might represent multiple marketed products over the course of the evolution of the device 510(k) and PMA downloads only include class II and III devices, omitting class I

The only current way to consolidate the information across these various databases in a reliable manner is via FOIA request. There have already been multiple requests for this data at regular refresh intervals. VALUE A single source for all registered medical devices is needed for core services on medical device insights provided to hospitals. In addition, without a single source of data, it is difficult for hospitals to understand the available substitutes for a given device. USE CASE SPECIFICATIONS & SOLUTION Information about this use cases is maintained in a wiki: http://hhs.ddod.us/wiki/Use_Case_5:_Consolidated_registry_of_marketed_me... It serves as a knowledge base. USE CASE DISCUSSION FORUM All communications between Data Users, DDOD Administrators and Data Owners are logged as discussions within GitHub issues: https://github.com/demand-driven-open-data/ddod-intake/issues/5 It aims to provide complete transparency into the process and ensure the same message gets to all participants. CASE STATUS Closed via openFDA.gov API, which includes medical device registration and listing as of September 2015.

Access & Use Information

Public: This dataset is intended for public access and use. License: See this page for license information.

Downloads & Resources

Dates

Metadata Created Date November 10, 2020
Metadata Updated Date November 10, 2020

Metadata Source

Harvested from Healthdata.gov

Additional Metadata

Resource Type Dataset
Metadata Created Date November 10, 2020
Metadata Updated Date November 10, 2020
Publisher U.S. Food and Drug Administration, Department of Health & Human Services
Unique Identifier Unknown
Maintainer
Identifier 7b744c79-fa97-4585-8a4e-514fc40a61de
Data First Published 2015-04-08
Data Last Modified 2018-11-16
Public Access Level public
Bureau Code 009:10
Metadata Context https://project-open-data.cio.gov/v1.1/schema/catalog.jsonld
Metadata Catalog ID https://healthdata.gov/data.json
Schema Version https://project-open-data.cio.gov/v1.1/schema
Catalog Describedby https://project-open-data.cio.gov/v1.1/schema/catalog.json
Data Quality True
Data Dictionary http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm134495.htm
Homepage URL https://healthdata.gov/dataset/ddod-establishment-registration-device-listing
License https://opendatacommons.org/licenses/odbl/1.0/
Program Code 009:005
Source Datajson Identifier True
Source Hash 0676502557808de49a47ea45d376f62fc727c8d4
Source Schema Version 1.1

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