Hello, my name is Barbara Zimmerman, I am a Deputy
Director in CDRH's Office of Regulatory Programs and
one of the Center's leads in tracking our
performance under the medical device user fee
agreement.
The Medical Device User Fee Amendments of 2017 -
or, MDUFA 4, for short - cover the period from
October 1, 2017 through September 30, 2022.
However, device user fees were first established by
Congress in 2002.
Medical device companies pay fees to FDA when they
register their establishment and list
their devices with the agency, whenever they
submit an application or a notification to market a
new medical device in the United States, and for
certain other types of submissions.
These fees - and the commitments that FDA makes
as part of the user fee agreements - provide a
mechanism for FDA to increase the efficiency of
regulatory processes in order to reduce the time
it takes to bring safe and effective medical devices
to the U.S.
market.
To help drive that efficiency, a core feature
of the MDUFA agreement are the performance goals.
The MDUFA 4 agreement includes two sets of
performance goals- "Review Performance Goals" are
objectives for FDA's review of the various
types of premarket submissions.
The MDUFA 4 agreement was noteworthy - among other
reasons - for including performance goals for our
review of De Novo submissions for the first
time.
"Shared Outcome Goals" are (as the name implies)
objectives that both FDA and applicants share
responsibility for achieving.
Shared Outcome Goals are intended to reduce the
average Total Time to Decision for premarket
applications and 510(k) submissions, while
continuing to maintain standards for safety and
effectiveness of the devices.
My discussion today will focus on FDA's performance
in meeting these goals over the first three years
of the MDUFA 4 agreement - which, I am proud to say,
has been very strong.
In addition, because the devices program has faced,
and continues to face, unprecedented challenges
in 2020 as we focus our time and resources on
battling the COVID-19 pandemic, I will touch on
how the pandemic response efforts have begun to
affect our ability to continue to meet MDUFA
performance goals in certain areas.
In total, the MDUFA IV agreement involves 25
goals: 23 review goals with specific target
percentages and 2 shared outcome goals.
This slide provides a snapshot of FDA's
performance in relation to these goals thus far.
As I said, FDA's performance in meeting the
MDUFA IV goals has been strong!
In fiscal year 2018 we have received submissions
for 21 of the 25 performance goals.
Of the 21 goals where we received submissions, FDA
met all 20 goals.
In fiscal year 2019 we received submissions for
20 of the 25 review goals.
Of the 20 goals where we received submissions, we
met the goal for 13 of them, we did not meet the
goal for one, and still have the potential to meet
6 more of the goals.
In fiscal year 20 all submission cohorts are
still open except for one.
The one submission cohort that has received enough
submissions to determine if we have met our goal is
for Pre-submissions.
I am please to say we have met our pre-submission
goal for fiscal year 2020.
You can also see this table, without the color
coding but with more details, in the MDUFA
Congressional Performance report which is listed as
a reference at the end of this slide deck.
This table includes 16 goals which apply to both
CDRH and CBER.
I have color coded each of the goals.
The goals that are green have met the performance
goal.
The goals that are yellow mean we do not have
sufficient data yet to calculate if we have met
or missed the performance goal.
We refer to this situation as "pending".
I will elaborate on this in a minute.
The goals that are red mean we have missed the
goal, the goals that are gray mean we did not
receive any submissions for that goal, and the
goals that are white mean we have not yet received
any submissions for that fiscal year or that fiscal
year has not begun.
FDA has done an excellent job in meeting the
performance goals listed in this table, as can be
seen by all the green boxes and only one red
box.
Performance goals are calculated based on the
year each submission was received.
We call this a receipt cohort.
For example the performance goal for
510(k) decisions is for FDA to review a submission
within 90 days 95% of the time.
This means that for all the 510(k) submissions
received in fiscal year 2018 we will wait until we
have made final decisions on almost all of them
before we are able to determine if we have met
this goal.
Until we reach the point where we can calculate if
we have met this goal we indicate that our
performance is pending.
The first table on this slide lists 7 goals which
only apply to CBER.
The second table or the bottom table lists 2
shared outcome goals.
Both of these tables follow the same color
coding as I just explained for the previous slide.
As you can see, CBER has done a great job meeting
their performance goals.
They met all the goals for which they received
submissions.
The Shared outcome goals are goals which FDA and
Industry have a shared commitment to achieve.
These are total time to decision goals where FDA
is responsible for reviewing the submission
in a timely fashion and industry is responsible
for providing any needed additional information in
a timely fashion, such that, together the total
time to decision goals are met.
There are shared outcome goals for 510(k) and PMA
Original and Panel Track Supplements.
At this point in time we only have sufficient data
to calculate the total time to decision goal for
fiscal year 2018.
We have met both the 510(k) and PMA shared
outcome goals for fiscal year 2018.
The Shared outcome goal for 510(k) was to achieve
a total time to decision within 124 days and the
shared outcome goal for PMA was to achieve a total
time to decision within 320 days.
Now I would like to take a few minutes to discuss the
EUA and pre-EUA submissions we have
received since the beginning of the calendar
year.
EUAs and Pre-EUAs are not part of the MDUFA IV
performance goals but have contributed heavily to our
workload this year.
Since the pandemic started in March, we have received
over 4500 pre-EUAs and EUAs.
In addition, FDA has issued more than 20
guidance documents related to medical devices as part
of COVID-19 pandemic response.
De Novo, PMA original, and panel track supplements
are contributing to the increase in number of
submissions under review.
This is an encouraging sign.
It's a signal that the pipeline for innovative
technologies appears to remain strong.
Which correlates with a record number of novel
devices for which we have received and issued EUAs
for over the past few months.
As I previously just mentioned this is a good
sign because the innovative technologies
remain strong, but it also means the staff have a lot
of work on their plate.
As you can see our total volume is significantly
higher than it was 1 year ago.
It is approximately double what it was last year at
this time.
While the preEUA and EUA submissions are driving
the doubling, we are also seeing increased workload
in our time intensive submissions such as De
Novo, PMA originals and panel track supplements
The organization's focus is on addressing the
pandemic needs before other non-pandemic related
work.
And then, submissions with MDUFA goals over work that
is not associated with the pandemic or MDUFA
performance goals.
It is no surprise that the increased volume of work
the organization is experiencing is putting a
strain on our ability to meet the MDUFA performance
goals.
The next few slides are examples of some signs of
strain we are seeing in our MDUFA data.
This graph is tracking the average time it takes to
make a MDUFA decision on a PMA Original or Panel
Track Supplement from fiscal year 2007 thru
fiscal year 2019 when each fiscal years cohort is
about 71% closed.
Please note at this point in fiscal year 2020 there
are very few submissions which have had a final
mdufa decision.
Therefore, that data is not included in the graph.
It will be added as soon as a mdufa decision has
been made on approximately 50% of the submissions
received in fiscal year 2020.
The data on this graph is showing us that the
average time to a MDUFA decision is increasing if
you compare the fiscal year 2018 and the fiscal
year 2019 cohorts.
The increase in average total time is being driven
by an increase in FDAs review time (the blue
line).
This increase in average review time for FDA is
largely being driven by the inability of FDA staff
to review submissions as quickly as they previously
were prior to the COVID-19 pandemic.
The data on this slide is showing the total number
of PMA Originals and Panel Track supplements that are
awaiting a MDUFA decision (these are pending
submissions) and the number of submissions we
have received in each fiscal year.
Please note the number of PMA Originals and Panel
track supplements for fiscal year 2020 is only a
partial year and will increase by the end of the
fiscal year.
As you can see, the number of pending submissions at
the present time is greater than it has been
in several previous years.
So far this year there is an increase of 11
applications as compared to 2019.
The increased number of pending PMA original and
panel track supplements is likely due to the
inability of FDA staff to complete the review of
these applications as quickly as they have been
prior to the COVID-19 pandemic.
The data on this graph is showing the trend in FDAs
510(k) decision goal performance.
The orange arrow on this graph is pointing to the
line which represents fiscal year 2020's
performance.
It is showing that at 10 months into the fiscal
year FDA is meeting its goal of reviewing 510(k)
submissions within 90 days 98.8% of the time.
While this level of performance is well above
our performance goal of reviewing 510(k)
submission in 90 days, 95% of the time, it is an
early indicator that we may struggle to achieve
our goal of 95% by the time the cohort has
closed, especially if it continues on its downward
trend.
In conclusion, FDA's overall MDUFA IV
performance has been strong.
We have consistently met our performance goals.
However the COVID-19 pandemic has put a
significant strain on our fiscal year 2020's ability
to meet user fee goals.
We will continue doing the best we can by
prioritizing our work and shifting our staff to the
areas which need the most assistance, but we do
expect our performance to further decline.
As always, our staff remain committed to doing
all that they can to support the country's
efforts to combat the pandemic while continuing
to support our critical non-COVID priorities,
particularly those related to MDUFA.
I have listed a few resources on this slide
which go into greater detail about our user fee
performance goals and current progress in
meeting those goals.
The link to each of these resources is embedded in
the slide.
Thank you for your attention today.
Please stay safe.