MDUFA for FDA 510k Submission (Medical Device User Fee Amendments)

The Medical Device User Fee Amendments (MDUFA) play a pivotal role in the 510(k) submission process for medical devices in the United States. MDUFA allows the FDA to collect fees from medical device manufacturers for reviewing premarket submissions.

These fees are essential for funding the FDA’s activities, ensuring that medical devices approved or cleared for the market meet safety and efficacy standards.

Overview of MDUFA

The MDUFA was first established in 2002, has been periodically reauthorized, with the most recent updates continuing to govern the review of medical devices.

The MDUFA requires medical device manufacturers to pay user fees when submitting applications for FDA premarket review.

MDUFA applies to various types of submissions, including Premarket Approval (PMA) applications, 510(k) Premarket Notifications, De Novo requests, 513(g), Panel-track Supplement, etc. These fees are an important revenue stream, supporting the FDA’s ability to meet its regulatory responsibilities.

510(k) Submission and MDUFA

510k submission is a premarket notification submitted to the FDA where device manufacturers demonstrate that their product is substantially equivalent to a legally marketed device (known as a predicate device).

This submission pathway is most commonly used for Class I and Class II devices. As part of the 510(k) submission process, manufacturers are required to pay a 510(k) application fee as part of the review process.

These fees are mandatory for manufacturers seeking FDA 510k clearance for their devices which helps cover the costs of processing and reviewing their submissions.

MDUFA Fee Structure for 510(k) Submissions

The FDA publishes an updated MDUFA fee annually. For the Fiscal Year 2025 (October 1, 2024, through September 30, 2025), the 510(k) submission fees are as follows:

· Standard 510(k) Fee: $24,335

· Small Business 510(k) Fee: $6,084

The FDA offers fee reductions for qualified small businesses. To qualify for the small business fee reduction, the following must be met:

 The business must demonstrate that its gross receipts or sales (including those of any affiliates) are $100 million or less for the most recent tax year.

Companies must submit signed copies of the most recent federal income tax returns document for the business and any affiliates.

Manufacturers must create an account in the FDA User Fee System to receive an Organization ID number (Org ID), which is required for the application.

U.S.-based companies must complete Form FDA 3602, while foreign businesses should submit Form FDA 3602A. These forms are available for download on the FDA’s website.

After completing the forms along with the required financial documentation, Beginning November 1, 2024, businesses must submit Small Business Determination (SBD) requests electronically via the CDRH portal. There is no fee for this submission.

The FDA will review the submission within 60 days and notify the company of its eligibility, granting a Small Business Decision Number to claim the reduced fee if approved.

Small business status must be renewed each fiscal year by submitting updated financial information.

Payment Types

Electronic Payments (such as credit cards or ACH electronic checks).

Mailing in a Paper check drawn on a U.S. bank in U.S. currency

Wire Transfers

Steps to pay User fee electronically

FDA offers your organization the ability to complete a Medical Device User Fee Cover Sheet online and submit it electronically.

Refer to the FDA website for the latest fees applicable for the 510(k) submission type. Create or login to the FDA Device Facility User Fee website.

Select the “510(k) Cover Sheet” option and fill out the required information, including the device name, applicant name, and contact information.

Review and confirm the drafted cover sheet. Submit the cover sheet to FDA to obtain a Payment Identification Number (PIN).

Pay the correct (standard or small business ) MDUFA fee using approved methods once the cover sheet is submitted and Payment Identification Number (PIN) is obtained. If eligible for the small business fee, provide the SBD number.

Once payment proceeded, print the completed cover sheet and include it with the 510(k) submission.

Conclusion

The FDA Medical Device User Fee Amendments (MDUFA) are essential for funding the FDA’s evaluation of medical devices while ensuring high safety and efficacy standards.

Understanding MDUFA fees, particularly for 510(k) submissions, helps manufacturers navigate the clearance process efficiently. By planning for fees and timelines, manufacturers can avoid delays and bring devices to market faster. Staying informed about MDUFA updates ensures alignment with changes in fee structures and performance goals.

Written By
Ruksana Sanafar
Sr. Consultant, FDA Complaince | Medical Device

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Clinical Evaluation Report becomes an essential document in terms of safety and performance of the device to prove that a device is safe and performs as intended. These are the key components of a successful CER within the framework of MDR 2017/745.

Scope and Objectives of Clinical Evaluation

The first and foremost stage in the preparation of the Clinical evaluation report includes and emphasizes the clear definition of its respective scope and objectives. Aspects of this include defining the description of the device, of its intended purpose.

This must include risk classification of the device and any regulatory approvals the device has obtained under MDR 2017/745. It should serve to define articulation between the rationale and aims of clinical evaluation.

Device Description

A thorough description of the device is essential. This should provide information on its design, mechanism of action, and intended use.

Device descriptions should also identify the salient functions that differentiate it from existing products. A comprehensive understanding of the device helps in evaluating clinical performance and safety.

State of the Art

It is called the “state of the art” requirement to compare the device against what is currently regarded as the most appropriate practice in medicine. This involves describing relevant current standards, clinical guidelines, and medical practices concerning the device’s intended use. Thus, a standard against which the device performance will be measured is established.

Clinical Data Sources

A strong clinical evaluation report (CER) should incorporate pertinent clinical data from diverse sources: clinical investigation, literature reviews, and post-market clinical follow-up (PMCF).

Appraisal for relevance, quality, and clinical importance should be adopted for all sources of clinical evidence. This appraisal step guarantees that only high-quality data will support conclusions in the CER.

Clinical Evaluation Plan (CEP)

Clinical Evaluation Plan sets the procedural records for every clinical evaluation. It defines the intended use of the device, its applicable clinical data, and techniques of evaluating and analysing the data. The CEP provides a systematic approach through which clinical evaluation is transparent and reproducible.

Identification and Critical Appraisal of Clinical Data

At the heart of the CER is the identification, the collection, and the critical appraisal of relevant clinical data. This data can include pre-market clinical trials, PMCF studies, or published literature. The CER would have to assess the relevance and quality of the data by whether it supports the intended claims of the device.

The appraisal process itself involves the evaluation of clinical study design, methodology, and outcomes. The data are to be evaluated for validity, reliability, and applicability to the target patient population. The CER must also consider gaps in clinical evidence and possible ways to bridge these gaps.

Risk-Benefit Analysis

The clinical evaluation report should consider the degree of adverse events, complications, and safety hazards linked with the device and compare these with anticipated clinical benefits. It is crucial to integrate data collected throughout the device lifecycle through post-market surveillance.

It is important to incorporate data collected during the lifecycle of the device via Post-Market Surveillance (PMS). As part of PMS, data is used for the continual evaluation of the performance and safety of the device.

It comprises reports from users, information on adverse events, and any newly available clinical evidence. The CER remains up to date by periodically updating it with PMS data.

Post-Market Surveillance and Clinical Follow-Up

The MDR 2017/745 gave specific emphasis on Post market surveillance and post-market clinical follow-up as continuous monitoring safety and performance of medical devices.

The CER has to describe the post-market surveillance system and clinical follow-up activities to collect further evidence after the placing of the medical device. This should include plans for real-world clinical data collection and analysis, e.g. adverse event reporting, registries, and patient monitoring.

Conclusion

A Clinical Evaluation Report (CER) is crucial for manufacturers to ensure the safety and performance of their devices. Key components of a successful CER include defining the scope and objectives, giving a detailed description of the device, comparing it with current standards and providing all relevant clinical data from various sources.

The Clinical Evaluation Plan (CEP) is the set of procedural records set for every evaluation in order to make evaluation processes transparent and reproducible. Moreover, the knowledge of clinical areas, regulatory requirements, and clinical evaluation methods is crucial when it comes to expertise.

Post-Market Surveillance (PMS) for patient safety is important for feedback in the proper and ongoing solicitation of performance and safety data. It ensures that the CER is updated, frequently available, and accurate for all relevant stakeholders.

AUTHOR

Dr Minu Lazar, BDS (Junior Consultant CER)

REFERENCE

1. MEDDEV 2.7/7 revision 4, clinical evaluation: a guide for manufactures and notified bodies under directives 93/42/EEC and 90/385/EE

2. MDCG 2020–5 Clinical Evaluation — Equivalence

3. European Commission. (2017). Medical Device Regulation (MDR) 2017/745.

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