Transcript Medical device reports are increasing

Center for Devices and Radiological
Health
MassMedic May 2006
Larry Kessler, Sc.D.
Director, Office of Science and
Engineering Laboratories, CDRH
The State of the World: CDRH
• How are we doing premarket?
• How are we doing on compliance efforts?
• How are we doing on surveillance?
• How are we doing on communication?
• What are new scientific challenges and how do
they connect to FDA Critical Path Initiative?
Comparison of CDRH FY 2004 vs FY 2005 Payroll Expenditures
By Strategic Area
(Shown in Millions - excludes CLIA Resources)
$80.0
$67.6
$70.0
$60.0
$50.0
Millions
$40.0
FY 2004
$30.0
FY 2005
$16.2
$20.0
$10.0
$11.0
$12.4
$3.5
$7.3
$0.0
RCHSA
Device
Science
Activities
Device
Device
Device
Compliance Postmarket Premarket
Activities
Assurance Evaluation
Activity
MQSA
Major Submissions Received (FY 99 – FY 04)
TYPE OF
SUBMISSION
1999
2000
2001
2002
2003
2004
Original PMAs
64
67
71
49
54
51
PMA Supplements
557
546
641
645
666
635
Original IDEs
304
311
284
312
242
226
510(k)s
4,458
4,202
4,248
4,320
4,247
3,635
Total
9,801
9,775
10,282
10,323
9,879
9,064
MDUFMA Implementation
Reducing Review Time
Performance Goals
FY 03 Cohort
FY 04 Cohort
FY 05 Cohort
FY 06 Cohort
(as of Dec 31, 2005)
Original PMAs and
Panel-track
Supplements
Goal
Actual
Goal
Actual
Goal
Actual
Goal
Actual
—
91.1%
—
91.1%
—
100%
80%
—
—
100%
—
100%
70%
100%
80%
—
—
96.1%
80%
97.8%
80%
100%
75%
96.4%
75%
100%
Decision ≤ 320 days
Expedited PMA
Decision ≤ 300 days
180-day PMA
Supplements
COMPLETED
—
COMPLETED
Decision ≤ 180 days
510(k)
Decision ≤ 90 days
94.1%
—
75.7%
COMPLETED
COMPLETED
—
83.6%
New and Innovative Devices
ExAblate 2000 System
SurgiChip
The first surgical marker with
RFID technology
The first to combine magnetic
resonance imaging and focused
ultrasound to target and destroy
uterine fibroids
Invader UGT1A1 Molecular Assay
The first DNA-based test for a drug metabolizing enzyme (Personalized
drug treatment decisions and drug therapy)
Premarket Review Quality Assessment Pilot
Program
Ensuring Quality in Premarket Review
• The goal is to assess quality of review of
premarket submissions using retrospective
(post-decision) peer assessments
• Pilot focuses on 3 areas of review:
– Biocompatibility
– Sterilization/Packaging
– Statistics
Medical device recalls are increasing
638
608
Class 1 Recalls
600
Total Recalls
546
495
486
500
533
480
Trendline
400
336
300
200
100
29
5
4
FY 98
FY 99
8
14
7
23
23
FY 01
FY 02
FY 03
FY 04
FY 05
0
FY 00
* FY 2005 Data as of 9/13/05
Medical device reports are increasing
REPORTS RECEIVED - FY 2000 - 2005
Other
Malfunction
Injury
Death
200,000
180,000
Number of Reports
160,000
In FY 05 CDRH
received about
176,000 reports
140,000
120,000
100,000
>1,125,000 total
80,000
60,000
40,000
20,000
0
2000
2001
2002
2003
Fiscal Year
2004
2005
We are working on critical postmarket issues
• Strengthening Condition of Approval studies
• Improving targeted surveillance systems: MedSun
• Focusing on risk-based inspections
• Implementing third party inspections
• Better communicating risk/benefit information
• Improving our automated information systems
Working together to improve postmarket
safety…
• FDA collaborated in a postmarket workshop with
AdvaMed
• FDA, the Heart Rhythm Society and industry reps
are exploring opportunities to improve Product
Performance reports, PMA Annual reports and
standardize our Dear Doctor letter format
• FDA’s Defibrillation Working group focus on
postmarket
• Additional areas of active collaboration include
recalls and unique device identifiers
Our Communication Strategy
We're improving our automated information systems...
• Easy-to-use databases of regulated products
• Routinely-asked questions and answers
• Developing methods of collecting and
disseminating (“pushing out”) CDRH news
• Improving CDRH web pages:
– Medical Device Recalls - a web-friendly, plain
language overview of medical device recalls
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/
cfTopic/medicaldevicesafety/recalls.cfm
New Technology
The GI Tract Camera
•
Important Trends
– Miniaturization
– Intelligent Devices
– Minimally invasive
– Biotechnology Revolution
– New Materials
– Combination Products
– Disruptive Technologies
• That change how we do
business
• That change how medical
devices deliver value
What’s the Critical Path?
Market
Application
Basic
Research
Prototype
Design or
Discovery
Preclinical
Development
Clinical
Development
Approval
FDA Filing/
Approval &
Launch
Preparation
Critical Path
Critical Path is the FDA's premier initiative to identify and
prioritize the most pressing medical product development
problems and the greatest opportunities for rapid
improvement in public health benefits.
CDRH Research Program
(Efficient, Effective, and Predictable Product Development)
High Intensity Focused Ultrasound (HIFU)
ISSUE
The lack of standardized methods to assess the acoustic and
thermal characteristics of the focused beams
ACCOMPLISHMENTS
In a device for the ablation of uterine fibroids, CDRHdeveloped computational modeling to predict the
performance of the device under conditions that would have
been difficult to investigate experimentally, thus shortening
the review time
Medical Imaging and Diagnostics Laboratory
DIAM, OSEL CDRH, FDA
and
NIBIB/CDRH Laboratory for the Assessment of
Medical Imaging Systems
×5
×2.5
×1
×3.5
g
×1
f
f
h
×1.5
b
c
×1
a
×1
×1
d
×0.5
e
×1
×0.5
×0.5
High-performance
computing
Cone-beam CT
scanning x-ray tube
Tomosynthesis
Pathological
Coronary
Anatomy
Classification:
Type I:
a
Type II:
a, b, c
Type III:
d, e
Type IV:
f, g, h
Computer phantom of
cardiovascular disease
Colonic polyp CAD
detector
q
Computer-aided
immunohistochemical imaging
Bone sonometry
X-ray, electron, and photon transport simulation
planes of
reconstruction
Display evaluation: physical characterization and observer studies
Characterization of Optical Diagnostic
Device Performance
• Test methods for Optical
Coherence Tomography (OCT)
devices
– Imaging OCT point spread function
with nanoparticles
• Computational modeling of
fiber-optic probe designs
used in fluorescence-based
neoplasia detection
100
Depth
200
microns
300
400
500
600
700
800
0
100
200
300
400 500
microns
600
700
800
1 mm
Pregnant Women Exposed to Hand
Held Metal Detectors
Information Technology
Using and Developing Improved IT
Systems put into production in 2005 and 2006:
• Three CTS (Center Tracking System) “subsystems”
–
–
–
Device Nomenclature Management System (DNMS)
Condition of Approval Tracking System (COATS)
eConsult
• OIVD Turbo 510(k)
Systems under development:
• eMDR (electronic submittal receipt of adverse event
reports)
• PPOMP (Pre-market Program Operations Modernization Project)
• OC Tracking – This will also be a “subsystem” within CTS