Get the free Medical Device User Fee Cover Sheet, Form FDA 3601 - gpo

This document is used to collect information for processing user fees associated with medical device applications to the FDA.

How to fill out medical device user fee

How to fill out Medical Device User Fee Cover Sheet, Form FDA 3601

1. Obtain Form FDA 3601 from the FDA website or your regulatory affairs department.
2. Fill out the applicant information, including the name, address, and contact details of the manufacturer or representative.
3. Provide device information, including the device name, common name, and product code.
4. Indicate the type of submission (e.g., new device application, 510(k), PMA) in the designated section.
5. Specify the fee category that applies to your submission (e.g., full fee, small business discount).
6. Review the Payment section to confirm the mode of payment (credit card, check, etc.) and include payment information.
7. Complete the certification area, ensuring all authorized representatives sign and date the form.
8. Make a copy for your records before submitting the form with your application.

Who needs Medical Device User Fee Cover Sheet, Form FDA 3601?

1. Manufacturers or representatives of medical devices who are submitting applications or notifications to the FDA.
2. Any entity that is required to pay a user fee for their submission under the Medical Device User Fee Amendments (MDUFA).

People Also Ask about

What are the payment methods for the FDA?

18. How to pay for an LTO application? Payment OptionCredit via Landbank ATM Card Real-time Credit* Other Banks via Bancnet Next banking Day* Cash Payments via 7/11 and Bayad Center Next Banking Day* *for transactions made during holidays and weekends, payment will be credited on the next banking days

How do I pay my FDA user fee?

The fastest way to pay is credit card, electronic check, or wire transfer. The slower method is by mailed check. You will need to add the PIN number to your mailed checks and wire transfers. Narrative: If you pay by electronic check, use the form on the top; for credit card use the form on the bottom.

How to pay FDA fine?

Accepted Payment Methods: Bank account (ACH) PayPal account. Venmo account. Debit or credit card.

How do I pay my FDA annual fee?

Payment Options Fastest payment option via credit card, electronic check (ACH), or wire transfer (PIN must be included in wire transfer) takes 2-3 business days after payment date.

Who pays FDA user fees?

To support its public health activities, the FDA relies on (1) annual funding that Congress provides for the agency, and (2) Congressionally-authorized user fees paid by industries that make and market FDA-regulated products, and paid by certain other entities.

How much is the FDA medical device user fee?

FDA unveils FY 2025 user fee rates MDUFA Application TypeFY 2024FY 2025 Small Business $8,462 $9,464 510(k) $21,760 $24,335 Small Business $5,440 $6,084 30-Day Notice $7,737 $8,65314 more rows • Aug 1, 2024

How much of the FDA budget is user fees?

Before FDA can begin its review of a 513(g) Request for Information submission, the applicant must pay the user fee. For fiscal year 2025, which began on October 1 and runs through September 30, 2025, the standard fee is $7,301. If the applicant has been certified as a small business by FDA, the fee is $3,650.

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What is Medical Device User Fee Cover Sheet, Form FDA 3601?

The Medical Device User Fee Cover Sheet, Form FDA 3601, is a form required by the FDA for applicants submitting a medical device application, including premarket approval applications (PMAs) and premarket notification submissions (510(k)s). It serves as a means to collect fees that are mandated by the Medical Device User Fee Amendments.

Who is required to file Medical Device User Fee Cover Sheet, Form FDA 3601?

Any person or entity that submits a medical device application to the FDA, including manufacturers, importers, distributors, and representatives, is required to file the Medical Device User Fee Cover Sheet, Form FDA 3601.

How to fill out Medical Device User Fee Cover Sheet, Form FDA 3601?

To fill out Form FDA 3601, applicants must provide information such as their name and address, the type of submission being filed, and details regarding the device being submitted. Accurate information on the user fee payment must also be included, along with any applicable exemptions or waivers.

What is the purpose of Medical Device User Fee Cover Sheet, Form FDA 3601?

The purpose of the Medical Device User Fee Cover Sheet, Form FDA 3601, is to formally accompany medical device submissions to the FDA and facilitate the collection of user fees, which are used to fund the medical device review process, ensuring timely evaluations of new devices.

What information must be reported on Medical Device User Fee Cover Sheet, Form FDA 3601?

The following information must be reported on Form FDA 3601: applicant's name, address, contact information, submission type, device information (including the product code and device name), payment information, and whether any exemptions or waivers apply.