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Establishment Registration and Medical Device Listing Files

Provided By: John Snow Labs

Establishment Registration and Medical Device Listing Files

Provided By: John Snow Labs

This data package contains access to lists of owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (manufacturers, distributors, importers, agents and others).

Product offers

The following offers are available for this product. Choose an offer to view the pricing and access duration options for the offer. Select an offer and continue to subscribe. Your subscription begins on the date that you accept the offer. Additional taxes or fees might apply.

Public offer

Payment schedule: Upfront payment | Offer auto-renewal: Supported
$0 for 12 months

Overview

Overview

This data package contains datasets on medical device establishment including foreign firms that manufacture medical devices, registered and non-registered importers with the Food and Drug Administration (FDA) listed by manufacturers, detailed list of the types of device establishments that are required to register at FDA and pay the fees. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also provide the FDA premarket submission number (510(k), PMA, PDP, HDE, De Novo). This data package allows access to all related data.


License Information

The use of John Snow Labs datasets is free for personal and research purposes. For commercial use please subscribe to the Data Library on AWS. The subscription will allow you to use all John Snow Labs datasets and data packages for commercial purposes.


Metadata

DescriptionValue
Data Package ComplexityMedium
Available EnrichmentsN/A
KeywordsNon-Registered Importers, Medical Device Importers, Product Code, Medical Device Listing, US Agent MD, Establishment US Agent, FDA Medical Device
Other TitlesFDA Medical Device Listing, FDA Medical Device Registration, FDA Medical Device Operators Lists

Included Datasets

  1. Medical Device Establishment Contact Addresses

    This dataset showcases the establishment and listing provided by the FDA (Food and Drug Administration) with the location of medical device establishments and a list of devices manufactured at those establishments.

  2. Medical Device Establishment Official Correspondent

    Medical Device Establishment Official Correspondent dataset contains Medical Device Establishment Registration Official Correspondent Information. Most establishments that are required to register with the Food and Drug Administration (FDA) are also required to list the devices that are made there and the activities that are performed on those devices.

  3. Medical Device Establishment Owner Operator

    The U.S. Food and Drug Administration (FDA) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. For devices that are exempt from Premarket Notification, Manufacturers (both domestic and non-U.S.) and initial distributors (importers) of medical devices must register their establishments with the U.S. FDA. The operators of such establishments are found in this dataset.

  4. Medical Device Establishment Types

    Medical Device Listing Establishment Types dataset contains the description of each Establishment Type ID. For combination products, identify the type of the combination (i.e., drug/device, etc.)

  5. Medical Device Establishment US Agent

    This dataset contains the Medical Device Establishment US Agent Information. Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment.

  6. Medical Device Listing Establishment Types

    Manufacturers (both domestic and foreign) and initial distributors (importers) of medical devices must register their establishments with the FDA (Food and Drug Administration). All establishment registrations must be submitted electronically unless a waiver has been granted by FDA.

  7. Medical Device Listing Product Code

    This dataset contains Medical Device Listing Product Code information. Classification product codes are a method of internally classifying and tracking medical devices. CDRH and a subset of CBER regulated medical device product codes consist of a 3 letter combination which associates a device’s type with a product classification designated for the application. The information associated with these devices, such as names and attributes, are assigned by CDRH to support their regulation.

  8. Medical Device Listing Proprietary Name

    This dataset shows establishments that are required to register with the Food and Drug Administration (FDA) which are also required to list the devices that are made and the activities that are performed on those devices.

  9. Medical Device Manufacturers Identified by Importers

    This dataset shows foreign firms that manufacture medical devices and/or products that emit radiation that are imported into the United States must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories. In order to import medical devices and/or products that emit radiation into the U.S., the product must meet FDA regulatory requirements. Food and Drug Administration (FDA) does not recognize regulatory approvals from other countries.

  10. Medical Device Non-Registered Importers Identified by Manufacturers

    This dataset shows establishments that are required to register with the Food and Drug Administration (FDA) that are also required to list the devices that are made there and the activities that are performed on those devices.

  11. Medical Device Registered Importers Identified by Manufacturers

    This dataset contains details of Medical Device Importers. Establishments that are required to register with the Food and Drug Administration (FDA) are also required to list the devices that are made there and the activities that are performed on those devices.

  12. Medical Device Registration Listing

    This dataset shows owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the Food and Drug Administration (FDA).

  13. Medical Device Registration

    Detailed list of the types of device establishments that are required to register and pay the fee can be found in this dataset. This dataset also contains Medical Device Establishment Registration Information including registration keys and full addresses of establishments.


Data Engineering Overview

We deliver high-quality data
  • Each dataset goes through 3 levels of quality review
    • 2 Manual reviews are done by domain experts
    • Then, an automated set of 60+ validations enforces every datum matches metadata & defined constraints
  • Data is normalized into one unified type system
    • All dates, unites, codes, currencies look the same
    • All null values are normalized to the same value
    • All dataset and field names are SQL and Hive compliant
  • Data and Metadata
    • Data is available in both CSV and Apache Parquet format, optimized for high read performance on distributed Hadoop, Spark & MPP clusters
    • Metadata is provided in the open Frictionless Data standard, and its every field is normalized & validated
  • Data Updates
    • Data updates support replace-on-update: outdated foreign keys are deprecated, not deleted

Our data is curated and enriched by domain experts

Each dataset is manually curated by our team of doctors, pharmacists, public health & medical billing experts:

  • Field names, descriptions, and normalized values are chosen by people who actually understand their meaning
  • Healthcare & life science experts add categories, search keywords, descriptions and more to each dataset
  • Both manual and automated data enrichment supported for clinical codes, providers, drugs, and geo-locations
  • The data is always kept up to date – even when the source requires manual effort to get updates
  • Support for data subscribers is provided directly by the domain experts who curated the data sets
  • Every data source’s license is manually verified to allow for royalty-free commercial use and redistribution.

Need Help?


About Us

John Snow Labs , an AI and NLP for healthcare company, provides state-of-the-art software, models, and data to help healthcare and life science organizations build, deploy, and operate AI projects.

Provided By
Fulfillment Method
AWS Data Exchange

Data dictionaries

A data dictionary is a visual representation of the contents of a data set. The data represented here is for evaluation purposes only and may not accurately represent the actual content of the product.

Field name
Description
Example
Data type
Primary key
Nullable
Max length
Data set
Table name
Table description
Address_Id

Establishment address Id

-
integer
-
false
-
Medical Device Establishment Contact Addresses
medical_device_establishment_contact_addresses
Contact_Id

Establishment contact Id

-
integer
-
false
-
Medical Device Establishment Contact Addresses
medical_device_establishment_contact_addresses
Address_Line1

Address of the Establishment, 1st line

-
string
-
-
-
Medical Device Establishment Contact Addresses
medical_device_establishment_contact_addresses
Address_Line2

Address of the Establishment, 2nd line

-
string
-
-
-
Medical Device Establishment Contact Addresses
medical_device_establishment_contact_addresses
City

City of the Establishment

Miami

string
-
-
-
Medical Device Establishment Contact Addresses
medical_device_establishment_contact_addresses
State_Code

State code of the Establishment

-
string
-
-
-
Medical Device Establishment Contact Addresses
medical_device_establishment_contact_addresses
State_Province

State province of the Establishment

-
string
-
-
-
Medical Device Establishment Contact Addresses
medical_device_establishment_contact_addresses
Iso_Country_Code

Country of the Establishment

-
string
-
-
-
Medical Device Establishment Contact Addresses
medical_device_establishment_contact_addresses
Postal_Code

Postal code of the Establishment

-
string
-
-
-
Medical Device Establishment Contact Addresses
medical_device_establishment_contact_addresses
Registration_Key

Registration Key of the Establishment

-
integer
-
false
-
Medical Device Establishment Official Correspondent
medical_device_establishment_official_correspondent

Data sets (13)

You will receive access to the following data sets

Revision access rules
All historical revisions | All future revisions
Name
Type
Data dictionary
AWS Region
Medical Device Registration Listing
Included
US East (N. Virginia)
Medical Device Registration
Included
US East (N. Virginia)
Medical Device Registered Importers Identified by Manufacturers
Included
US East (N. Virginia)
Medical Device Non-Registered Importers Identified by Manufacturers
Included
US East (N. Virginia)
Medical Device Manufacturers Identified by Importers
Included
US East (N. Virginia)
Medical Device Listing Proprietary Name
Included
US East (N. Virginia)
Medical Device Listing Product Code
Included
US East (N. Virginia)
Medical Device Listing Establishment Types
Included
US East (N. Virginia)
Medical Device Establishment US Agent
Included
US East (N. Virginia)
Medical Device Establishment Types
Included
US East (N. Virginia)
Medical Device Establishment Owner Operator
Included
US East (N. Virginia)
Medical Device Establishment Official Correspondent
Included
US East (N. Virginia)
Medical Device Establishment Contact Addresses
Included
US East (N. Virginia)

Data dictionaries and samples

Sample data is for evaluation purposes only and may not accurately represent the actual content of the product.

Name
Resource
File type
File size
Description
Medical Device Establishment Contact Addresses
Data set
-
-
-
Data dictionary
Data dictionary
text/csv
-
data_preview.csv
Sample
text/csv
Preview of Medical Device Establishment Contact Addresses dataset
Medical Device Establishment Official Correspondent
Data set
-
-
-
Medical Device Establishment Owner Operator
Data set
-
-
-
Medical Device Establishment Types
Data set
-
-
-
Medical Device Establishment US Agent
Data set
-
-
-
Medical Device Listing Establishment Types
Data set
-
-
-
Medical Device Listing Product Code
Data set
-
-
-
Medical Device Listing Proprietary Name
Data set
-
-
-
Medical Device Manufacturers Identified by Importers
Data set
-
-
-
Medical Device Non-Registered Importers Identified by Manufacturers
Data set
-
-
-
Medical Device Registered Importers Identified by Manufacturers
Data set
-
-
-
Medical Device Registration Listing
Data set
-
-
-
Medical Device Registration
Data set
-
-
-

Usage information

By subscribing to this product, you agree that your use of this product is subject to the provider's offer terms including pricing information and Data Subscription Agreement . Your use of AWS services remains subject to the AWS Customer Agreement  or other agreement with AWS governing your use of such services.

Support information

Support contact email address
Refund policy
No refunds offered. For any questions email us at info@johnsnowlabs.com
General AWS Data Exchange support