FDA - Medical Device Establishment Registration: 2024 fees
Foreign medical device establishment registration is a crucial step for manufacturers and importers of medical devices looking to operate within the United States. In this comprehensive guide, we'll break down the essential details of this process, including the registration fees, requirements, and key deadlines. The new FDA Medical Device Establishment Registration for 2024 is $7,593.00.
Registration and Renewal Timeline
The registration process is an annual requirement that must be completed within specific timeframes:
October 1st - December 31st: Annual verification and renewal of medical device facility registration.
Why Registration Matters
Both domestic and foreign medical device manufacturers and importers are mandated by the FDA to register their establishments annually. Failure to comply can result in serious consequences, including detention or refusal of medical device products.
U.S. Agent Designation
Foreign manufacturers must also designate a U.S. Agent, an entity located in the United States that acts as the representative for the facility before the FDA. This individual or organization plays a vital role in liaising with regulatory authorities on your behalf. Your US Agent must help you with the FDA fees 2024.
FDA Medical Device Fees 2024
Congress has granted the FDA the authority to collect establishment registration fees for 2024. These fees are as follows:
- **Fiscal Year 2023:** $6,493 (October 1, 2022 - September 30, 2023)
- **Fiscal Year 2024:** $7,653 (October 1, 2023 - September 30, 2024)
For businesses approved under the Small Business Decision, it's crucial to note that your approval letter expires on September 30th. To maintain certification with the Center for Devices and Radiological Health (CDRH) as a small business, a new approval letter is required effective October 1st.
Establishment Registration and Listings
All establishments must complete their establishment registration fee payment between October 1st and the end of December. Any changes to registration and listings cannot be finalized until the annual fee is settled. Failure to pay the renewal fee by the end of December will result in the automatic suspension of your account.
For more detailed information and to start the registration process, visit [FDA's official website]https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa
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