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Establishment Registration and Medical Device Listing Files
Provided By: John Snow Labs
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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).
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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
Description | Value |
---|---|
Data Package Complexity | Medium |
Available Enrichments | N/A |
Keywords | Non-Registered Importers, Medical Device Importers, Product Code, Medical Device Listing, US Agent MD, Establishment US Agent, FDA Medical Device |
Other Titles | FDA Medical Device Listing, FDA Medical Device Registration, FDA Medical Device Operators Lists |
Included Datasets
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.
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.
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.
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.)
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.
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.
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.
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.
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.
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.
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.
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).
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?
- If you have questions about our products, contact us at info@johnsnowlabs.com.
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
Support contact URL
Refund policy
No refunds offered. For any questions email us at info@johnsnowlabs.com
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