HHS U.S. Department of Health and Human Services

Account Management

Create New Account

Create New Account

ERROR: While submitting the form, please correct the error(s) and re-submit.

You must create a separate account to create your Medical Device Registration and Listing or Food Facility.

Step 1: Select Application(s) for Account Creation

Select the systems you will need to access

Do you conduct work for a State Agency under Contract with the FDA?
If you are creating an account on behalf of a manufacturer, please select "No."

Yes

Registration and Listing Programs

Food

Acidified/Low-Acid Canned Foods Registration
and Process Filing Food Facility Registration/Qualified Facility Attestation

Qualified Facility Attestation

Medical Devices

Device Registration and Listing Module

Are you creating this account to register a medical device and listing for more than one company?

Yes No

Warning: You should create a separate account for each owner/operator to register their medical device establishment.

Export Listing Module

Shell Egg Producer Registration

Export Certification and Tracking

Biologics Export Certification Application and
      Tracking System (BECATS) CDRH Export Certification Application and
      Tracking System (CECATS) CVM Export Certification Application and
      Tracking System (CVM eCATS)

Are you a Foreign Government Official?

Yes No

CDER Export Certification Application and
Tracking System (CDER eCATS) HFP Export Certification Application and
Tracking System (HFP eCATS)

Includes FDA-regulated food and cosmetics.

FSMA Program(s)

Accredited Third-Party Certification Program--
Accreditation Body

Check this box if you are an AB and are submitting an application for FDA recognition.

Accredited Third-Party Certification Program--
Certification Body

Check this box if you are a CB who needs to create an account. You must have a verification code to complete your account setup. FDA will send you the verification code via email after you have been accredited by a recognized AB.

FSVP Importer Portal for FSVP Records Submission

Check this box if you are an FSVP importer who needs to use a secure portal to submit FSVP records requested by FDA.

Laboratory Accreditation for Analyses of Foods Program--
Accreditation Body

Check this box if you are an AB and are submitting an application for FDA recognition.

Laboratory Accreditation for Analyses of Foods Program--
Accredited Lab

Check this box if you are an accredited lab and are creating an account. You must have a verification code to complete your account setup. FDA will send you the verification code via email after you have been accredited by a recognized LAAF AB.

Voluntary Qualified Importer Program

Other FDA Systems

Prior Notice System Interface Import Trade Auxiliary Communication System (ITACS)

ITACS

Please select your firm's official role(s) in the importation of FDA-regulated products. You may select more than one if applicable.

Importer of Record Consignee Filer (Licensed Customs Broker)

CDER Office of Manufacturing Quality (CDER OMQ e-Portal)

CBER Biological Product Deviation Reporting (CBER eBPDR) Observations and Corrective Action Report (OCAR) Industry Portal

ERROR: Please select any of the systems you wish to register.

Cancel

Clear Continue