Key Differences between Medical Device User Fees and Establishment Registration and Listing

1. TOPIC:
Key Differences Between Medical Device User
Fees & Establishment Registration and Listing
Author: Heena Thakkar
CATEGORY:
Basics of US FDA Regulations – Medical Devices

2. Summary:-
When it comes to submitting an application to the regulatory agency, there are a lot of steps
involved to win the final battle i.e. getting a clearance/approval from the authority.
One of the key steps to make that process smoother is to be able to submit required payments to
the Agency. Successful payments save the time and help to meet the regulatory requirements.
In the US FDA’s world of medical devices, certain payments are required as well before and after the
submission process i.e. Medical Device User Fees and Registration Fees.
Paying Medical Device User Fee is important because FDA would not accept the submission until
the fee is paid. Similarly, for not registering an establishment and listing a device as required would
be a violation of FDA’s regulatory requirements.
A list of key differences between the two are covered in this presentation along with the References
for detailed information.

3. Sr. No. Medical Device User Fees Establishment Registration & Listing
1 Medical Device User fee is paid to the Agency
(FDA) for a product review by the applicant
who wishes to market the medical device in
the US.
Establishment Registration fee is paid to the
Agency (FDA) by those that are involved in the
production and distribution of medical devices in
the US.
2 First introduced in 2002 as MDUFMA/MDUFA I
(FY03 - FY07) > Revised in 5 years to MDUFA II
(FY08 - FY12) > MDUFA III (FY13 - FY17) >
MDUFA IV (FY18 - FY22).
Section 510 of FD&C Act (The Act) was amended
in 1976 that introduced provisions for
establishment registration & Listing > The Act was
revised in 2007 under FDA Amendment Act
(FDAAA) which mandated electronic registration
& Listing and also published required user fees.
3 It is a 5 year program and the fee structure is
revised every 5-years prior to beginning of next
FY.
The fee structure is revised annually for every FY.
4 The current Medical Device User Fee program
is called MDUFA IV which is active for the
FY2018-FY2022.
(i.e. Oct 1,2017 – Sept 30, 2022)
The current Establishment Registration fee is for
FY 2020 (i.e. Oct 1,2019 – Sept 30, 2020).

4. 5 Small Businesses are eligible for reduced user
fees for each of their applications (as long as
they qualify for being considered as ’Small
Business’)
Establishment Registration fee is the same for
every business type.
6 The user fees differ based on the type of
application submitted for review as well as the
size of the business.
The fees for FY2020 is $5236.
7 The applicant is required to pay the fees before
submitting an application for review (e.g.
510(k))
The user is required to renew their registration
annually. For the first time users, they need to
register their establishment within 30 days of the
product being marketed and then maintain the
registration annually.
8 Small Businesses are also eligible for first pre-
market waiver fees (i.e. a small business
applicant submitting application for review for
the first time).
No such discount is available.
9 This is a single step process that involves
paying user fees via mail, courier or wire
transfer.
This is a multi-step process: Pay annual
registration fees > complete the registration
process > List the Device

5. 10 As applicable, Medical Device User Fee Cover
Sheet (Form 3601) is required along with the
payment.
The registration fee is paid on Device Facility User
Fee (DFUF) website. After successful payment,
the registration & listing information is submitted
on FURLS/DRLM website.
11 These fees apply to 510(k)s, PMAs, PDPs,
PMRs, Panel-Track Supplements, Efficacy
Supplements, 180-day Supplements, Real-
Time Supplements, 30-Day Notices/135-Day
Supplements, Biologics Licensing Applications
(BLAs for certain medical devices reviewed by
CBER), 513(g)s, and De-novo requests.
Establishments that are involved in the
production and distribution of medical devices
intended for commercial distribution in the U.S.,
including those that are imported for export only,
are required to register annually with the FDA
regardless of which type of application they will
submit for product review.
12 User fees are not required for third party
510(k) review, applications solely intended for
pediatric use, any application from state or
federal govt. entity etc.
No such exemptions available for this type of fee
regime.

6. References:
1. https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-
and-listing
2. https://www.fda.gov/medical-devices/device-registration-and-listing/how-register-and-list
3. https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-
and-pay-fee
4. https://www.fda.gov/training-and-continuing-education/cdrh-learn
5. https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-
mdufa
6. FY 2016 Medical Device User Fee Small Business Qualification and Certification - Guidance for
Industry, Food and Drug Administration Staff and Foreign Governments