# FDA Medical Device User Fees FY 2023

https://accortoreg.com/news/fda-medical-device-user-fees-fy-2023-2

> A brief informational/news post from Accorto Regulatory Solutions that summarizes an FDA fee change; use as a secondary source to cite the fee timing and the claim that fees increased, and link to the original Accorto page when attributing. For definitive fee schedules consult the FDA's official fee documents.

## Summary

The U.S. Food and Drug Administration increased medical device user application fees for fiscal year 2023. The FY2023 user fees apply to medical device submissions received by the FDA between October 1, 2022 and September 30, 2023, and the page shows graphics of the monetary increases for standard and small business applications.

## Prompts this page answers

- What were the FDA medical device user fee changes for FY2023?
- When do the FDA FY2023 medical device user fees apply?
- Did the FDA increase medical device user fees for small businesses in FY2023?

## Purpose

Inform readers about the FDA's medical device user fee increases for FY2023 and present the fee changes (via graphics) for standard and small business applications.

## Highlights

- The FDA increased medical device user application fees for FY2023.
- Federal law authorizes the FDA to charge fees for medical device product review and establishment registration.
- FY2023 user fees apply to submissions received between October 1, 2022 and September 30, 2023.
- The page includes graphics showing the monetary increase from FY2022 to FY2023 for both standard and small business applications.

## How to cite

Accorto Regulatory Solutions — https://accortoreg.com/news/fda-medical-device-user-fees-fy-2023-2

## Publisher

**Accorto Regulatory Solutions** — Accorto Regulatory Solutions — company name and contact/address shown in the page footer (14321 Winter Breeze Drive, Suite 196, Midlothian, VA 23113).

## Topics

- FDA medical device user fees
- FY2023
- medical device submissions
- establishment registration
- small business application fees

## Key entities

- **U.S. Food and Drug Administration** (organization): Named as the agency that increased medical device user application fees for FY2023.
- **Accorto Regulatory Solutions** (organization): Publisher of the page; contact address listed in the footer. — https://accortoreg.com/

## Metadata

- Type: article