Report from CDRH

1
Report from CDRH
MassMEDIC FDA Update Meeting December 8, 2005

• Donna-Bea Tillman, Ph.D
• Director, Office of Device Evaluation
• Center for Devices and Radiological Health

2
CDRH Mission Today
CDRH promotes and protects the health of the
public by ensuring the safety and effectiveness
of medical devices and the safety of radiological
products
Promote
Protect
3
But wait, theres more!
Monitor medical devices and radiological health
products for continued safety
Help the public get accurate, science-based
information needed to improve health
4
CDRH Vision

• Ensuring the health of the public through out the
  Total Product Life Cycle (TPLC)

5
CDRH Strategic Goals

• Goal 1 Public Health Impact
• Goal 2 Magnet for Excellence
• Goal 3 Knowledge Management
• Goal 4 Total Product Life Cycle (TPLC)

6
CDRH 2006 Priorities

• Increase our ability to identify, analyze and act
  on post-market information
• Increase communication of risk/benefit
  information to all of our stakeholders
• Continue to implement and assess MDUFMA 1 and
  prepare for MDUFMA 2
• Advance the "critical path" for medical and
  radiological products
• Invest resources strategically to support the
  priorities of HHS, FDA, and CDRH

7
CDRHs Balancing Act
Getting safe and effective devices to market as
quickly as possible
while ensuring that devices currently on the
market remain safe and effective.
Risks
Benefits
8
We're increasing our focus on Postmarket Safety

• Why?

FDA Temperature up over Cordis
9
Medical Device Recalls
FY 2005 Data as of 9/13/05
10
Were improving our ability to identify adverse
events that occur under specific conditions

• Who will be using the device?
• Special populations?
• How will they be using it?
• User error considerations?
• Long-term performance?
• Where will they be using it?
• Home use? Environmental factors?

11
Passive Surveillance Medical Device Reports

• We're improving passive surveillance by
• Beginning to develop electronic reporting tools
• Working to improve access, review and action on
  reports
• Working to improve access to additional sources
  of information

12
Enhanced Surveillance MedSun and LabSun
A national network of healthcare facilities
trained to recognize and report problems with an
active component that includes targeted
surveillance and networks able to provide
real-time data.

• We're improving our hospital and laboratory
  reporting system by
• Developing new tools and methods to improve the
  number and type of reports we receive
• Increasing laboratory reports from the
  participating hospitals
• Targeting laboratory reports (pathology and in
  vitro diagnostic tests)

13
We're strengthening our control of PMA Condition
of Approval studies by

• Involving epidemiology staff in PMA review
• Designing postmarket studies to address
  postmarket questions
• Transferring oversight to OSB
• Implementing a tracking system
• Following-up with sponsors when requirements are
  not being met

14
Risk-Based Inspections

• We're linking inspections to level of risk by
  
• Developing Risk Assessment Criteria that consider
  probability and severity of harm
• Focusing our limited field resources on medical
  devices and manufacturers that present the
  greatest risk to public health
• Leveraging Quality System

15
InspectionsWe're implementing two Third Party
Inspection programs by

• Issuing guidance
• Publishing criteria for accredited persons
• Selecting and training third parties to
  participate in the program
• Partnering with Canada to pilot implementation

• CDRHs Third Party Inspection Programs
• National/Domestic (MDUFMA)
• International Mutual Recognition Agreement
  (EU-MRA)

16
Risk Communication

• We are looking for more and better ways to
  communicate risk information to consumers, health
  care professionals, and industry

17
Improve Communication and Education
WWW.FDA.GOV/CDRH
18
We're getting information out through

• Patient Safety News www.fda.gov/psn
• Public Health Notifications www.fda.gov/cdrh/safet
  y.html
• One Pagers - New Device Approvals
• www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopi
  c/mda/mda-list.cfm?list1
• Listservs -- e.g. Breast Implants
  www.fda.gov/cdrh/bicl
• Disease- and product-specific websites -- e.g.
  Cochlear Implants www.fda.gov/cdrh/cochlear
• Device Advice website www.fda.gov/cdrh/devadvice/
  
• Consumer website www.fda.gov/cdrh/consumer/index.h
  tml

19
We're improving our automated information systems

• Developing easy-to-use databases of
  CDRH-regulated products
• Developing and posting a list of routinely-asked
  questions and answers
• Developing methods of collecting and
  disseminating (pushing out) CDRH news
• Improving CDRH web pages

20
Whats happening with the Premarket program?
21
MDUFMAs Challenge

• FDA will turn dollars into shorter review
  times

22
while maintaining our commitment to good
science.
23
Thats a lot of submissions!
24
How did we meet this challenge?
25
Hire the right people
Biologist
Biomedical Engineers
Medical Officers
Software Engineer
Statistician
Chemical Engineer
Nurses
26
Set milestones for review
320 days
PMA Received
Clock Stops
Filing Review
Filing Letter
Scientific Review
Scientific Review
Interactive Rev
Consults Complete
Panel Go/No Go
Status Letter
Panel Planning
Major Deficiency Letter
Panel Meeting
Closeout Review
Final Decision
27
Track each PMA individually
MDUFMA Decisions Completed
Non-Expedited PMA Goal MDUFMA decisions completed
in lt 320 days
320 Days
In Process (Includes under review on hold)
PMAs in Process
320 Days
PMAs with MDUFMA Decisions Completed
Note FY 04 cohort as of June 30, 2005
28
Measure our Performance
29
PMA/S Receipt Cohort Average Review Time to Final
Action
(ODE Annual Report 2004)
FY 04 ODE/OIVD FY 04 ODE Only
In FY04, 31 of PMA/S receipts were reviewed
Real-Time, with an average FDA time of 53 days.
30
Meeting the MDUFMA goals Review Process for
Traditional 510ks
We have a new process for 510ks
Final Decision (lt90 total days)
FDA Initial Review
Hold
Hold
Review
Review
Determination that significant additional info
needed
Determination that significant additional info
needed
31
And we are meeting the goals
(March 31, 2005)
32
but meeting the goals has taken a toll on CDRH
reviewers
33
Percent of 510(k) Receipts With Final Decision
for First Action
and had some unintended consequences
1st Qtr.
34
Percent of 510(k) ReceiptsStill Pending
AfterTwo FDA Review Cycles
FY 2004 cohort is not complete final percentage
will be 13-14.
35
What about the Science?
36
Program to Assess Quality of Premarket Reviews

• Pilot focuses on three cross-cutting areas
  biocompatibility, sterility, statistics
• Retrospective peer assessments of sampled reviews
• Quality assessment teams with defined criteria
• Results of pilot highlighted areas where
  additional training is needed
• Program to continue in these three areas, with
  new areas to be gradually incorporated

37
Technology trends

• Miniaturization
• Smart devices
• Minimally invasive
• Biotechnology revolution
• Combination Products
• Home use
• Special Populations

38
Disruptive Technologies

• That change the nature of medical devices
• That change how medical care is delivered
• That change health outcomes, hopefully for the
  better
• that change how the industry and FDA do business.

39
Challenges

• Basic biomedical science investment progress
  has surpassed medical product development
  investment and progress

40
Challenges

• We are using the evaluation tools and
  infrastructure of the last century

to develop this centurys advances.
41
Challenges

• This has resulted in a bottleneck at the
  critical path for delivering new products to
  patients

42
Critical Path Research

• Leverages basic science knowledge
• Leverages cumulative research experiences
• Does not compromise
• safety and effectiveness
• evaluations

43
Critical Path for Medical Devices
Market Application
Approval
Basic Research
Prototype Design or Discovery
Clinical Development
FDA Filing/ Approval Launch Preparation
Preclinical Development
Critical Path
The journey from medical product candidate to
full-scale production and marketing
44
Why is CDRH interested?

• Because of the significant benefit of bringing
  innovative products to the public faster
• Because of our unique perspective on product
  development -- we see success, failure and missed
  opportunities
• Because it will help us to develop guidance and
  standards that foster innovation and improve
  chances of success

Because it is good for Public Health!
45
What does CDRH want to accomplish?

• Work with industry, academia and patient care
  advocates
• to
• modernize, develop and disseminate solutions
  (tools) to address scientific hurdles impacting
  industry-wide product development.

46
What is ahead for 2006?
47
Improving Postmarket Safety

• Were are assessing the impact of our
  postmarket safety program and pinpointing areas
  that are in need of improvement.
• Were looking at the tools we use to identify
  problems, analyze problems and take action,
  either regulatory or information dissemination
  (or both.)
• Were looking into how to better coordinate our
  efforts, so we can have a better understanding of
  how devices are performing in the market.

48
CDRH Postmarket Safety Framework Improving Our
Postmarket Safety Programs
A network of programs and tools focused towards
minimizing harm and maximizing benefit associated
with the use of marketed medical devices. We
have compiled a comprehensive inventory of our
programs and plan to use gap analysis to identify
areas that need improvement.
49
Focused effort to improve COMPLETION of Guidance
Documents

• Developed single CDRH Guidance Priority List
• Assigned Senior Champions for each guidance
  document
• Established performance goals and tracking
  mechanisms
• Increased the use of contract experts to turn
  content into guidance

50
MDUFMA IPlanning for MDUFMA II

• With MDUFMA I weve
• Strengthened the review process
• Reduced review time
• Built a Center-wide culture that emphasizes
  coordination and accountability

• For MDUFMA II were
• Thoughtfully and systematically working to lay
  the groundwork for reauthorization as early as
  possible
• Trying to make the program better and stronger
  the second time around using current data and
  experience

51
Enhancements to IT Systems
CDRHs core business is information

• Managing this information has become increasingly
  difficult..
• There is just TOO much of it!

52
Electronic ReviewIs it the answer?

• Turbo 510k pilot for IVDs is well under way
• But participation from industry has been poor
• We are at the early stages of defining
  requirements for an ODE program
• eReview holds much promise for both FDA and
  Industry.

53
But we cant go it alone!

• If CDRH is to tame the paper jungle, we must
  have full support from industry

54
In the meantime..

• There is the eCopy program!
• Saves us resources () because we dont have to
  pay to Image submissions
• Could (potentially) improve review times!
• Details at
• http//www.fda.gov/cdrh/elecsub.html

55
There are many challenges ahead, but CDRH is
prepared to meet these challenges with

• A clear vision
• A comprehensive strategic plan
• Balanced and efficient resource management
• A staff that is dedicated to executing our plan

56
Questions?
Good judgment comes from experience, and
experience comes from bad judgment. -Barry
LePatner-