Important Information on Medical Device User Fees for Fiscal Year 2020 (October 1, 2019 through September 30, 2020)

Dear Medical Device Stakeholder:

This letter provides you with information about the annual establishment registration fees, small business designation and fees, and medical device user fees for Fiscal Year 2020 (FY2020), which runs from October 1, 2019, through September 30, 2020.

Federal law authorizes the U.S. Food and Drug Administration (FDA) to collect user fees for certain medical device submissions and establishment registration. On July 31, 2019, FDA announced the FY2020 user fees in a Federal Register notice titled Medical Device User Fee Rates for Fiscal Year 2020. User fees are required for the following types of medical device submissions:

premarket notifications (510(k)s)
premarket approval applications (PMAs)
product development protocols (PDPs)
some PMA and PDP supplements (for example, panel-track, 180-day, real-time, 30-day notice)
premarket reports (PMRs)
annual fee for periodic reporting on a class III device (PMAs, PDPs, and PMRs)
original biologics license applications (BLAs) for certain medical devices reviewed by FDA's Center for Biologics Evaluation and Research (CBER)
BLA efficacy supplements
requests for device classification information (513(g)s)
De Novo classification requests

In addition, all medical device establishments are required to pay an annual establishment registration fee.

FY2020 Fees for Establishment Registration

The annual establishment registration fee must be paid between October 1, 2019, and December 31, 2019. For FY2020, the registration fee for each establishment is $5,236 (in U.S. dollars). All establishments are required to pay the establishment registration fee. There are no waivers or reductions for small establishments, businesses, or groups.

The following educational resources on FDA’s Device Advice and CDRH Learn provide more information on the process for initial and annual registration of your medical device establishment:

Device Advice (text-based education)

Establishment Registration and Device Listing: Program Description

CDRH Learn (video-based education)

FY2019 Small Businesses: Fee Reduction and Fee Waiver for Certain Medical Device Submissions

To reduce the financial burden on small businesses, the FDA reduces the user fee for a qualified small business. “Small business” is defined as a business with $100 million or less in gross receipts or sales, including receipts or sales from its affiliates. In addition, if a small business has gross receipts or sales of $30 million or less, it is eligible to have the fee waived for its first PMA, PDP, PMR or BLA.

To receive the small business discount, you must be certified by the FDA as a small business. For information on how to apply for small business certification, please review the Medical Device User Fee Small Business Qualification and Certification Guidance. The FDA must first certify you as a small business before you may apply a small business fee reduction or waiver to a submission with a user fee.

Any business, regardless of location, may apply to be certified as a small business.

New Mailing Address for Small Business Certification Requests

The mailing address for the Small Business Program has been updated. Please send your requests for Small Business Certification to this address:

FY20__ MDUFA Small Business Qualification

Small Business Certification Program

10903 New Hampshire Avenue

Building 66, Room 5305

Silver Spring, MD 20993

U.S.A.

For Small Business submissions for FY2019, please enter “FY2019 MDUFA Small Business Qualification” in the first line of the address. For FY2020 submissions, please enter “FY2020 MDUFA Small Business Qualification.”

We will begin accepting Small Business Requests for FY2020 starting on August 1, 2019. FY2020 Small Business status will be from time of approval through September 30, 2020.

The Medical Device Small Business Guidance and associated forms are now applicable for all future fiscal years. We will no longer publish an annual guidance that expires at the end of the fiscal year. When filling out the required forms (Form FDA 3602 and Form FDA 3602A ), please identify the fiscal year for your request at the top of the form.

More information about the Small Business Program may be found at Device Advice:

Reduced Medical Device User Fees: Small Business Determination (SBD) Program

FY2020 User Fees for Medical Device Submissions

The following table identifies the FY2020 User Fees for Medical Device Submissions (in U.S. dollars).

510(k)‡ - Standard Fee 11,594. Small Business Fee 2,899.
513(g) - Standard Fee 4,603. Small Business Fee 2,302.
PMA, PDP, PMR, BLA - Standard Fee 340,995. Small Business Fee 85,249.
De Novo Classification Request - Standard Fee 102,299. Small Business Fee 25,575.
Panel-track Supplement - Standard Fee 255,747. Small Business Fee 63,937.
180-Day Supplement - Standard Fee 51,149. Small Business Fee 12,787.
Real-Time Supplement - Standard Fee 23,870. Small Business Fee 5,968.
BLA Efficacy Supplement - Standard Fee 340,995. Small Business Fee 85,249.
30-Day Notice - Standard Fee 5,456. Small Business Fee 2,728.
Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) - Standard Fee 11,935. Small Business Fee 2,984.

† For small businesses with an approved SBD.

‡ Note: All types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted by an FDA-accredited Third-Party Reviewer to the FDA.

The FY2020 user fees apply to medical device submissions received by the FDA on or after October 1, 2019. If you wish to pay the FY2019 user fee for a submission, both your submission and your user fee payment must be received prior to October 1, 2019.

If you plan to submit a submission to the FDA, the user fee payment must be received on or before the date you send the submission. The FDA will begin its review of a submission only after we receive your full payment.

Please do not send your user fee payment to the FDA with your application. You must submit your user fee separately through the Device Facility User Fee website. For additional information or instructions regarding how to submit the fee, please visit the Device Facility User Fee website.

For More Information

If you have questions regarding medical device user fees, regulatory requirements, or other related information, please contact the Division of Industry and Consumer Education (DICE) at the Center for Devices and Radiological Health (CDRH). Contact DICE at (800) 638-2041 or 301-796-7100 between 9:00 a.m. - 12:30 p.m. and 1:00 p.m. - 4:30 p.m. Eastern Time or by email at DICE@fda.hhs.gov.

Questions regarding products regulated by the Center for Biologics Evaluation and Research (CBER) should be directed to the Office of Communication, Outreach and Development (OCOD), Manufacturers Assistance and Technical Training (MATT) Branch. Contact CBER MATT at (800) 835-4709 or (240) 402-8010 or by email at industry.biologics@fda.hhs.gov.

Further information regarding medical device user fees and the implementation of MDUFA IV is available on the FDA Medical Device User Fee Amendments (MDUFA) website. On this site, you may also sign up to receive updates each time FDA updates information about MDUFA and other information relevant to the device industry. Fees for FY2021 will be published in the Federal Register 60 days before the start of that fiscal year.

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