CBER 510(k) Challenges and
Strategies
Susan Finneran
Director of Clinical and Regulatory Affairs
Background on Haemonetics
 NYSE traded company
 2,070 employees world wide
 Based in Braintree, MA.
 Hospital and blood collection customers in more than 80
countries
Vision:
To be the Global Leader in Blood Management
Solutions
2
Copyright © 2009 Haemonetics Corp.
We have a growing portfolio of customer
solutions
Hospital
Blood Center
Recruitment
& Interview
Blood
Collection
Processing
& Testing
Inventory &
Distribution
Hospital BB Transfusion
Inventory
Preparation
Intra Post
Point of Care
Blood Use
Optimization
Reports
Business Design
InSight™ Model
Dashboards
Pre
Information Management
Dashboards
TEG® cardioPAT
Cell
Saver®
MCS+
Cymbal®
Donor
Recruitment
Programs
PCS2
ACP®215
Automation Nation™
OrthoPAT®
Devices
Blood Collections
Optimization
Consulting Services
Business Solutions
Lean & Six Sigma
Blood Use Optimization
Consulting Services
Services
3
3
®
Copyright © 2009 Haemonetics Corp.
Haemonetics Devices
Automated Apheresis Devices
 Equipment, imbedded software
and disposable sets
 Submitted to CBER
 510(k) with clinical studies
 Recently down classified (Class II)
Autotransfusion Devices
 Equipment, imbedded software
and disposable sets
 Submitted to CDRH
 Class II
 Laboratory Studies
4
Copyright © 2009 Haemonetics Corp.
Types of 510ks submitted to CBER
Traditional – 90%
Special -10%
STED- none
Abbreviated- none
Third Party- not eligible for CBER devices
5
Copyright © 2009 Haemonetics Corp.
Premarket Notification Devices that are
submitted to CBER (Hematology Division)
 Automated Apheresis (Blood Collection) Systems
 Disposables used in blood collection
 Laboratory Equipment
 Blood Establishment Computer software
CDRH- 3700 510(k)s / year
CBER- 100 510(k)s / year
6
Copyright © 2009 Haemonetics Corp.
What else does CBER Review?
 BLA- Biologic License Applications
Blood Centers submit for a license to manufacture blood products
 NDA’s- New Drug Applications
Anticoagulant and Blood Nutrient solutions
 510(k)s- Premarket Notifications
Blood collection devices
 IDEs/INDs- Investigational Device Exemptions/
Investigation New Drug
Devices and solutions
 PMAs – Premarket approval
Not yet
7
Copyright © 2009 Haemonetics Corp.
Substantially Equivalent???
“That’s a CDRH term… that doesn’t
apply to CBER devices”
8
Copyright © 2009 Haemonetics Corp.
Substantially Equivalent is part of the equation..
 But more importantly… must meet Blood quality
standards
 Hemolysis at the end of storage
 Residual White blood cell content
 Red cell recovery after filtration
 Total hemoglobin in the blood product
 platelet count
9
Copyright © 2009 Haemonetics Corp.
Blood Quality standards can be found in…
 Guidance documents
 Memo’s to blood establishments
 Prior 510ks
 Transcripts from public meetings
BUT not in the Code of Federal Regulations??
10
Copyright © 2009 Haemonetics Corp.
Scenario #1 Plasma- Secret criteria
 Automated device already cleared to collect plasma
labeled as FFP (frozen within 6 hours)
 Very limited criteria published for plasma
 Clinical trial designed to qualify FFP and plasma frozen
within 24 hours
 FDA has a host of parameters which now must be tested
 Communication with competitors reveals everyone has a
slightly different list
11
Copyright © 2009 Haemonetics Corp.
#2 In vivo recovery: Higher is better
 IDE submitted for a trial to qualify an apheresis device for
collection of two units of red cells.
 Acceptance criteria includes in vivo recovery criteria
which has been applied in submissions for 10+ years.
 Upon submitting 510(k) FDA informs us there is not more
stringent criteria.
…public session one slide contained a reference to more
stringent criteria
 Communication with competitors reveals everyone has a
slightly different criteria.
12
Copyright © 2009 Haemonetics Corp.
#3 Tell me what you got and them we’ll tell you
the criteria
 Public meeting a new criteria is revealed for platelets
 Pre-meeting with FDA is held concerning acceptance
criteria for a clinical study
 Statistical boundaries were not defined
 FDA asked us to provide analysis with various confidence
levels, 90%, 95% and 99%
 FDA determines criteria based on our analysis
13
Copyright © 2009 Haemonetics Corp.
Effective Strategies
 Type C: pre- 510(k) meeting to discuss strategy
 Collaboration with competitors- let’s get in a room and
hash this out.
 Offer to develop guidance documents through a working
group
 Develop relationships with FDA to get a heads up about
what initiatives are in process
 IDE submission
 Request for meta-analysis of data for products marketed
 Fight fire with fire: Statistician as a resource
14
Copyright © 2009 Haemonetics Corp.
What can we learn from CBER
 Substantial equivalence is an antiquated term
 A new model will be developed to ensure safety and
effectiveness for non-PMA devices
 Performance standards will be developed
 FDA may want to raise the bar… but this must be based
on reality
 In God we trust all… all others bring data
 Access to a Statistician is critical
 FDA does not have enough resources.. get involved and help
to develop standards.
15
Copyright © 2009 Haemonetics Corp.
Thanks for your attention
Questions??
Comments???
ECO FRIENDLY (Print):
Click to add Conclusion Title
 Click to add Conclusion
 Second Level
 Third Level
 Fourth Level
 Fifth Level