Medical Device Registration

$79 / year

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.

Complexity

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), Premarket Approval (PMA), Product Development Protocol (PDP), Humanitarian Device Exemption (HDE)).
The amendments to the Medical Device User Fee Modernization Act require that after September 30th, 2007, all registration and listing information be submitted electronically, unless a waiver has been granted. The establishment registration fee is not eligible for a reduced small business fee.

Registration and listing provide FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the nation’s ability to prepare for and respond to public health emergencies.

Date Created

2013

Last Modified

2018-07-16

Version

2018-07-16

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

John Snow Labs Standard License

Source License Requirements

N/A

Source Citation

N/A

Keywords

Establishment Registration MD, Establishment Registration, MD Registration, Medical Device Establishments, MD Establishment Listing

Other Titles

Medical Device Establishment Registration, MD Establishment Registration

Name Description Type Constraints
Registration_KeyRegistration Key of the Establishmentintegerrequired : 1 level : Nominal
Registration_NumberRegistration Number of the Establishmentintegerlevel : Nominal
FEI_NumberFacility Establishment Identifier Numberintegerlevel : Nominal
Registration_Status_IDRegistration status IDintegerenum : Array level : Nominal
Is_Initial_Importer_FlagInitial importer flagboolean-
Registration_Expiry_DateRegistration expiry yeardate-
Address_TypeEstablishment Address typestringenum : Array
NameName of the Establishmentstring-
Address_Line_1Address of the Establishment, 1st linestring-
Address_Line_2Address of the Establishment, 2nd linestring-
CityCity of the Establishmentstring-
State_AbbreviationState code of the Establishmentstring-
Iso_Country_CodeCountry of the Establishmentstringrequired : 1
Zip_CodeZip code of the Establishmentstring-
Postal_CodePostal code of the Establishmentstring-
Registration_KeyRegistration_NumberFEI_NumberRegistration_Status_IDIs_Initial_Importer_FlagRegistration_Expiry_DateAddress_TypeNameAddress_Line_1Address_Line_2CityState_AbbreviationIso_Country_CodeZip_CodePostal_Code
2189365false2018UNAUS
2203955false2018UNAUS
2198775false2018UNAUS
2196695false2018UNAUS
55966961556130062483111false2018UNAUS
98496804017230028066121false2018UNAUS
12634804364710001840341false2018UNAUS
11491804115030002398971false2018UNAUS
14835968059230052044351false2018UNAUS
14010968022230031549161false2018UNAUS