Regulatory operations workspace

MDUFA Cover Sheet

Form FDA 3601 preparation, fee logic, validation, PDF, and Oracle AR export

Unofficial preparation tool
This application does not submit information to FDA. The official MD... payment identification number is created only in FDA's MDUFA cover-sheet system. Generated PDFs are visibly marked as preparation copies.

Step 1 of 8

Confirm submission scope and timing

Start with the expected FDA receipt date and submission category. These answers determine the fiscal-year schedule, fee category, and whether Form FDA 3601 is required.

MDUFA-R01 / R02

Use the date FDA is expected to receive the complete submission. The federal fiscal year runs October 1 through September 30.

How do I obtain this?

Use the center shown in FDA correspondence, the submission portal, or prior application records. Most device submissions are reviewed by CDRH; certain device-related biologics are reviewed by CBER.

Why the exact category matters

MDUFA fees are set by submission type. A periodic report may be fee-bearing but invoice-only, while a third-party 510(k) and specified supplements do not use Form FDA 3601.

Select a submission category to evaluate the cover-sheet requirement.
Detected fee schedule Not determined
Standard - Small business - Establishment -
Advanced: manually maintained fee rate

Use only when the FDA receipt date falls outside the built-in FY 2025-FY 2027 schedules or FDA has published a corrected rate. Record the authoritative source.

Draft stored only in this browser

Research-backed configuration

MDUFA rules and sources

Operational control: FDA's official system and current published guidance remain authoritative. Confirm rates and eligibility again on the actual FDA receipt date.

Implemented rules

Primary references