Services to Ease FDA Regulatory Compliance

Establishment

* Establishment Name
* Street Address
* City   * State
* Country   * Postal Code
FDA Registration Number   DUNS / EIN Number

Establishment Contact

* Name of Contact Person
* Job Title
* Mailing Address
* City   * State
* Country   * Postal Code
* Tel Number   * E-mail
Other business Names

Type of Operation

US Importer / Distributor

US Importer Name
FDA Registration Number   DUNS Number
Address
E-mail   tel Number

Manufacturer (For US Facility Only)

US Importer Name
FDA Registration Number   DUNS Number
Address
E-mail   tel Number

Medical Device - 1

* Proprietary Name
* Common Name

Medical Device - 2

Proprietary Name
Common Name

Medical Device - 3

* Proprietary Name
* Common Name

Medical Device - 4

Proprietary Name
Common Name

Medical Device - 5

Proprietary Name
Common Name

Medical Device - 6

Proprietary Name
Common Name

Description of Service and Cost

 Description of Service  Fees  Number of services  Total Fees
 Establishment Registration, US Agent/Official Correspondent.  USD 449.00
 (Annually)

       $  
 Device Listing (additonal devices)  USD 50/device
       $  
 Label Review (optional)
 USD 649/device        $  
 FDA Registration Fee for the Year 2017  USD 3382.00    Pay directly to FDA        ------
     Total  $  

Agreement for Drug Establishment Registration with US FDA

It is a long established fact that a reader will be distracted by the readable content of a page when looking at its layout. The point of using Lorem Ipsum is that it has a more-or-less normal distribution of letters, as opposed to using 'Content here, content here', making it look like readable English. Many desktop publishing packages and web page editors now use Lorem Ipsum as their default model text, and a search for 'lorem ipsum' will uncover many web sites still in their infancy. Various versions have evolved over the years, sometimes by accident, sometimes on purpose (injected humour and the like).

It is a long established fact that a reader will be distracted by the readable content of a page when looking at its layout. The point of using Lorem Ipsum is that it has a more-or-less normal distribution of letters, as opposed to using 'Content here, content here', making it look like readable English. Many desktop publishing packages and web page editors now use Lorem Ipsum as their default model text, and a search for 'lorem ipsum' will uncover many web sites still in their infancy. Various versions have evolved over the years, sometimes by accident, sometimes on purpose (injected humour and the like).

It is a long established fact that a reader will be distracted by the readable content of a page when looking at its layout. The point of using Lorem Ipsum is that it has a more-or-less normal distribution of letters, as opposed to using 'Content here, content here', making it look like readable English. Many desktop publishing packages and web page editors now use Lorem Ipsum as their default model text, and a search for 'lorem ipsum' will uncover many web sites still in their infancy. Various versions have evolved over the years, sometimes by accident, sometimes on purpose (injected humour and the like).

It is a long established fact that a reader will be distracted by the readable content of a page when looking at its layout. The point of using Lorem Ipsum is that it has a more-or-less normal distribution of letters, as opposed to using 'Content here, content here', making it look like readable English. Many desktop publishing packages and web page editors now use Lorem Ipsum as their default model text, and a search for 'lorem ipsum' will uncover many web sites still in their infancy. Various versions have evolved over the years, sometimes by accident, sometimes on purpose (injected humour and the like).

Submitter name Job Title Submitter E-mail
Translate »