Others titles
- Medical Device Establishment Types
- MD Establishment Types
Keywords
- Establishment Registration MD
- Medical Device Establishment Types
- Medical Device Listing
- Medical Device Types
- Medical Device Establishments
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.
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Description
Medical Device Listing Establishment Listing Types contains Establishment Type ID of each Establishment linked to Registration Key and Registration Listing ID. All registration information must be verified annually between October 1st and December 31st of each year. In addition to registration, foreign manufacturers must also designate a U.S. Agent. Beginning October 1, 2007, most establishments are required to pay an establishment registration fee.
The Food and Drug Administration Amendments Act (FDAAA) of 2007 requires that all registration and listing information (Annual, Initial or Updates) be submitted electronically unless FDA grants a waiver.
About this Dataset
Data Info
Date Created | 2013 |
---|---|
Last Modified | 2024-06-10 |
Version | 2024-06-10 |
Update Frequency |
Weekly |
Temporal Coverage |
N/A |
Spatial Coverage |
United States |
Source | John Snow Labs; U.S. Food and Drug Administration (FDA); |
Source License URL | |
Source License Requirements |
N/A |
Source Citation |
N/A |
Keywords | Establishment Registration MD, Medical Device Establishment Types, Medical Device Listing, Medical Device Types, Medical Device Establishments |
Other Titles | Medical Device Establishment Types, MD Establishment Types |
Data Fields
Name | Description | Type | Constraints |
---|---|---|---|
Registration_Key | Registration Key of the Establishment | integer | level : Nominalrequired : 1 |
Registration_Listing_Id | Registration Listing ID of the Establishment | integer | level : Nominalrequired : 1 |
Establishment_Type_Id | Establishment Type ID, each ID represent an Establishment Type according to this list: | integer | level : Nominalrequired : 1 |
Data Preview
Registration Key | Registration Listing Id | Establishment Type Id |
5 | 576175 | 5 |
5 | 576175 | 11 |
6 | 10860 | 5 |
6 | 10860 | 11 |
16 | 2 | 5 |
16 | 4 | 5 |
16 | 5 | 5 |
16 | 6 | 5 |
16 | 7 | 5 |
16 | 8 | 5 |