Medical Device Listing Establishment Types

$179 / year

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.

Complexity

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.

Date Created

2013

Last Modified

2019-09-23

Version

2019-09-23

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

NameDescriptionTypeConstraints
Registration_KeyRegistration Key of the Establishmentintegerrequired : 1 level : Nominal
Registration_Listing_IdRegistration Listing ID of the Establishmentintegerrequired : 1 level : Nominal
Establishment_Type_IdEstablishment Type ID, each ID represent an Establishment Type according to this list:integerrequired : 1 level : Nominal
Registration KeyRegistration Listing IdEstablishment Type Id
5108565
55714865
557148611
55761755
557617511
6108605
61086011
1625
1635
1645