Forms & CDRH Submission Portals
Key FDA submission portals
| Portal | Purpose | URL |
|---|---|---|
| FURLS | Establishment registration & device listing | accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl |
| GUDID / AccessGUDID | UDI device information submission & search | accessgudid.nlm.nih.gov |
| FDA eSubmitter (eCopy) | Electronic premarket submissions (eCopy Program) | FDA website |
| FDA ESG | Electronic Submissions Gateway (HL7 ICSR MDRs) | esgportal.fda.gov |
| eMDR | Electronic Medical Device Reports | FDA website |
| ClinicalTrials.gov | IDE study registration | clinicaltrials.gov |
| Regulations.gov | Public comment on proposed rules (FDA dockets) | regulations.gov |
Key FDA forms for device submissions
| Form | Purpose |
|---|---|
| FDA Form 3881 | Indications for Use — required in every 510(k), De Novo, HDE |
| FDA Form 2891 | Establishment registration |
| FDA Form 2892 | Device listing |
| FDA Form 3500A | MedWatch mandatory adverse event reporting (MDR) |
| FDA Form 3417 | MDR Baseline Report |
| FDA Form 3419 | User Facility Annual MDR Report |
| FDA Form 3514 | Application for Customised Labelling / Humanitarian Use Device |
All forms are available at FDA's forms catalogue.
Q-Submission (Pre-Submission) portal
The Q-Submission program allows manufacturers to request informal FDA feedback before filing a premarket submission. Types include:
- Pre-submission (Pre-Sub) — written questions with a proposed meeting
- Informational meeting — general discussion (no written questions required)
- Submission Issue Request (SIR) — questions arising during an active review
- Study Risk Determination — SR vs NSR determination for IDE studies
Q-Subs are submitted via the CDRH Customer Collaboration Portal (CCP):
CDRH contact and submission address
Center for Devices and Radiological Health
Document Mail Center — WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993
For electronic submissions via eCopy Program, see the current eCopy instructions on FDA's website.
Official resources
All FDA submission portals require secure user account creation and may require multi-factor authentication. Designate authorized personnel and maintain secure access credentials — unauthorized access to submissions is a regulatory violation.