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.