CDRH Portal Overview and Feature 

Walkthrough

Nelson Anderson

CDRH Portal Platform Owner

Office of Regulator Programs

Office of Product Evaluation and Quality (OPEQ)

Center for Devices and Radiological Health (CDRH)

U.S. Food and Drug Administration (FDA)
2
Evolving Program

• The CDRH Customer Collaboration Portal is continually 

being enhanced, so some of the details of this 

presentation may no longer be entirely accurate. 

• See the Portal Help articles (inside the Portal) for the 

most up-to-date information.

3
Learning Objectives

• Describe the purpose of the CDRH Portal

• Discuss what submissions can be uploaded through the 

CDRH Portal

• List what submissions can tracked in the CDRH Portal

4
What is the CDRH Portal? 

The CDRH Portal (Customer Collaboration Portal) 

is secure website that allows industry to:

• Upload CDRH-led premarket submissions to 

CDRH

• Track the progress of supported premarket 

submissions

5
Uploading Through the Portal

6
Uploading Through the Portal 

• Anything that is mailed to the CDRH document 

control center (DCC) can be uploaded through the 

Portal

• Uploads are limited to 4GB

• Nothing physical need be sent for a file uploaded 

through the Portal

7
Uploading Through the Portal 

• Cover letters should be included in PDF format 

(does not apply to eSTAR)

• There are no file name requirements, but logical 

file names that help our DCC identify the file

− Example: K23#### AI response.zip 

• Uploads completed after 16:00 EST will be 

processed the next normal business day

8
Uploading Through the Portal 

• Submit as 1 single file

• Starting on 1 Oct 2023, all 510(k)s must be 

submitted in eSTAR format through the Portal

Guidance: Electronic Submission Templated for Medical Device 510(k) Submissions

www.fda.gov/regulatory-information/search-fda-guidance-documents/electronicsubmission-template-medical-device-510k-submissions

9
Tracking a Submission

• Portal currently supports the progress tracking:

− 510(k)s: Traditional, Special, Abbreviated 510(k)s 

− Pre-Submissions 

• Tracking of a submission is initially only available to the 

Official Correspondent on record 

• Official Correspondent can share the progress tracking with 

other Portal users

10
HELP

11
How Do I Find Out More?

• Portal Help (inside the Portal) 

― Answers to many commonly asked questions 

― Instructions on how to use features such as the progress tracking 

“Share with others”

• Anyone can self-register for a Portal Account 

• To find links to the Portal and to the self-registration 

page, do a web search for “FDA send and track”

12
13
14
15
Submission Tracker

16
17
Track Progress of your submission 

18
Track Progress of you Submission 

19
20
Send a Submission- Format selection

21
22
5. Send a Submission File Selection
7. Send a Submission Loading File

24
25
9. Send a Submission

26
Summary

• The CDRH Portal can be used to track the progress of:

– 510(k)s (Traditional, Abbreviated, Special)

– Pre-Submissions (Written feedback, Meeting request)

• Submissions that can be mailed to the CDRH document 

control center can also be uploaded through the CDRH 

Portal

27
Industry Education

1. CDRH Learn – Multi-Media Industry Education

 over 200 modules - videos, webinars, presentations, software-based “how to” 

modules

 accessible on your portable devices: www.fda.gov/CDRHLearn

2. Device Advice – Text-Based Education

 comprehensive regulatory information across the device total product life cycle: 

www.fda.gov/DeviceAdvice

3. Division of Industry and Consumer Education (DICE)

 Email: DICE@fda.hhs.gov

 Phone: 1-800-638-2041 or (301) 796-7100 (9 am – 12:30 pm; 1 – 4: 30 pm ET)

28
Your Call to Action

1. Use the CDRH Portal to upload your 

submission to CDRH

– Remember: Starting on October 01, 2023, all 510(k)s must 

be submitted in eSTAR format through the Portal

2. Track the progress of your submission

― For near real-time submission status

29