켐론FDA코리아켐론FDA코리아

CONTACT US ENG

NEWS

Comprehensive up-to-date news coverage by Chemron FDA Korea.

News

공지 FY2021 FDA Medical Device User Fee 공지
등록일 : 2020-08-05    조회수 : 922


Important Information on Medical Device User Fees for Fiscal Year 2021 (October 1, 2020 through September 30, 2021)

Dear Medical Device Stakeholder:

This letter provides you with information about the annual establishment registration fees, the small business program, and medical device user fees for Fiscal Year 2021 (FY2021), which are effective October 1, 2020, through September 30, 2021.

Federal law authorizes the United States (U.S.) Food and Drug Administration (FDA) to collect user fees for certain medical device submissions and establishment registration. On August 3, 2020, FDA announced the FY2021 user fees in a Federal Register notice titled Medical Device User Fee Rates for Fiscal Year 2021. 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.

FY21 Fees for Establishment Registration

The annual establishment registration fee must be paid between October 1, 2020, and December 31, 2020. For FY2021, the registration fee for each establishment is $5,546 (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)

CDRH Learn (video-based education)
  1. Device Establishment Registration and Listing: Overview 
  2. Paying the Annual Registration User Fee via the Device Facility User Fee (DFUF) Website
  3. FURLS Device Registration and Listing: Annual Registration
  4. FURLS Device Registration and Listing: Initial Registration

FY21 Small Businesses: Fee Reduction and Fee Waiver for Certain Medical Device Submissions

To reduce the financial burden on small businesses, the FDA reduces the medical device 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 more information, 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.  We will begin accepting Small Business Requests for FY2021, starting on August 1, 2020. FY 2021 Small Business status will be from time of approval through September 30, 2021.

FY2021 User Fees for Medical Device Submissions

The following table identifies the FY21 User Fees for Medical Device Submissions (in U.S. dollars).
  • 510(k)‡ - Standard Fee $12,432. Small Business Fee $3,108.
  • 513(g) - Standard Fee $4,936. Small Business Fee $2,468.
  • PMA, PDP, PMR, BLA - Standard Fee $365,657. Small Business Fee $91,414.
  • De Novo Classification Request - Standard Fee $109,697. Small Business Fee $27,424
  • Panel-track Supplement - Standard Fee $274,243. Small Business Fee $68,561.
  • 180-Day Supplement - Standard Fee $54,849. Small Business Fee $13,712.
  • Real-Time Supplement - Standard Fee $25,596. Small Business Fee $6,399.
  • BLA Efficacy Supplement - Standard Fee $365,657. Small Business Fee $91,414.
  • 30-Day Notice - Standard Fee $5,851. Small Business Fee $2,926.
  • Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) - Standard Fee $12,798. Small Business Fee $3,200.
† For small businesses with an approved small business determination.

‡ 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 FY2021 user fees apply to medical device submissions received by the FDA on or after October 1, 2020. If you wish to pay the FY2021 user fee for a submission, both your submission and your user fee payment must be received prior to October 1, 2021.

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. For additional information or instructions regarding how to submit the fee, please visit the

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 FY2022 will be published in the Federal Register 60 days before the start of that fiscal year.

                                      

U.S. Food and Drug Administration
10903 New Hampshire Avenue, Silver Spring, MD 20993


위로