cber 510(k) challenges and strategies susan finneran director of clinical and regulatory affairs
TRANSCRIPT
CBER 510(k) Challenges and Strategies
Susan Finneran
Director of Clinical and Regulatory Affairs
Copyright © 2009 Haemonetics Corp.2
Background on Haemonetics
NYSE traded company2,070 employees world wideBased in Braintree, MA. Hospital and blood collection customers in more than 80
countries
Vision: To be the Global Leader in Blood Management
Solutions
Copyright © 2009 Haemonetics Corp.3
BloodCollection
Processing& Testing
Inventory &Distribution
Hospital BBInventory
Transfusion Preparation
Recruitment& Interview Point of Care
Pre Intra Post
HospitalBlood Center
Blood Use Optimization
Reports
Dashboards
Business DesignInSight™ Model
Dashboards
Automation Nation™
Business SolutionsLean & Six Sigma
Blood Collections Optimization
Consulting Services Blood Use OptimizationConsulting Services
Donor Recruitment
Programs
Cymbal®
PCS2
MCS+
TEG® cardioPAT®
OrthoPAT®
Cell Saver®
Information Management
Devices
Services
We have a growing portfolio of customer solutions
ACP®215
3
Copyright © 2009 Haemonetics Corp.4
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
Copyright © 2009 Haemonetics Corp.5
Types of 510ks submitted to CBER
Traditional – 90%
Special -10%
STED- none
Abbreviated- none
Third Party- not eligible for CBER devices
Copyright © 2009 Haemonetics Corp.6
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
Copyright © 2009 Haemonetics Corp.7
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
Copyright © 2009 Haemonetics Corp.8
Substantially Equivalent???
“That’s a CDRH term… that doesn’t apply to CBER devices”
Copyright © 2009 Haemonetics Corp.9
Substantially Equivalent is part of the equation..
But more importantly… must meet Blood quality standards
Hemolysis at the end of storageResidual White blood cell content Red cell recovery after filtrationTotal hemoglobin in the blood productplatelet count
Copyright © 2009 Haemonetics Corp.10
Blood Quality standards can be found in…
Guidance documents Memo’s to blood establishmentsPrior 510ksTranscripts from public meetings
BUT not in the Code of Federal Regulations??
Copyright © 2009 Haemonetics Corp.11
Scenario #1 Plasma- Secret criteria
Automated device already cleared to collect plasma labeled as FFP (frozen within 6 hours)
Very limited criteria published for plasmaClinical trial designed to qualify FFP and plasma frozen
within 24 hoursFDA has a host of parameters which now must be testedCommunication with competitors reveals everyone has a
slightly different list
Copyright © 2009 Haemonetics Corp.12
#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.
Copyright © 2009 Haemonetics Corp.13
#3 Tell me what you got and them we’ll tell you the criteria
Public meeting a new criteria is revealed for plateletsPre-meeting with FDA is held concerning acceptance
criteria for a clinical studyStatistical boundaries were not definedFDA asked us to provide analysis with various confidence
levels, 90%, 95% and 99%FDA determines criteria based on our analysis
Copyright © 2009 Haemonetics Corp.14
Effective Strategies
Type C: pre- 510(k) meeting to discuss strategyCollaboration with competitors- let’s get in a room and
hash this out.Offer to develop guidance documents through a working
groupDevelop relationships with FDA to get a heads up about
what initiatives are in process IDE submissionRequest for meta-analysis of data for products marketedFight fire with fire: Statistician as a resource
Copyright © 2009 Haemonetics Corp.15
What can we learn from CBER
Substantial equivalence is an antiquated termA new model will be developed to ensure safety and
effectiveness for non-PMA devicesPerformance standards will be developedFDA 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.
Thanks for your attention
Questions??
Comments???
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