# Presentation: 109292

## CBER/CDRH Harmonization Efforts   

**Sally Hojvat, Ph.D. OIVD/CDRH**
**                                                       **
**Paul Mied, Ph.D. OBRR/DETTD/CBER**
**                                                       **
**Sheryl Kochman MT (ASCP) OBRR/DBA/DRB/CBER**
**April 19, 2006**

## FDA Intercenter Agreement CBER/CDRH 1991    

- Non -binding guidance related to product jurisdiction
- Based on the existence of a working relationship between CBER & CDRH for certain categories of medical devices
- "Centers to coordinate activities in a consistent manner“
- CDRH designated lead center in FDA for regulating medical devices for safety and effectiveness (FD&C Act)
- CBER designated lead center in FDA for regulating medical devices for safety and effectiveness (FD&C Act and PHS Act )

- _[http:/](http://www.fda.gov/cber/dap/devpubs.htm)__[www.fda.gov/cber/dap/devpubs.htm](http://www.fda.gov/cber/dap/devpubs.htm)_

## FDA Intercenter Agreement (cont.) 

- CBER: lead responsibility for:
- Collection, processing, storage or admin. of blood products and components.
- Screening and Confirmatory blood bank clinical lab tests required for donor screening
- Diagnostic tests for all retroviral detection devices. (HIV/HTLV)
- QA reagents used in blood banking , anti-human globulins, blood grouping reagents, reagent RBCs and LAL
- Collection devices, specimen containers
- Software programs for data management in blood banks

## "Special  Situations" 

- IVD tests or reagents for direct or indirect detection of infectious agents
- e.g. CMV, Yersinia, Syphilis, Chagas transmitted by blood and blood products
- CDRH: lead when intended only for diagnostic use (not retroviruses)
- CBER: lead when intended only for blood donor screening use
- CDRH: lead when intended for both diagnostic and blood donor screening.
- Each Center reviews appropriate intended use claims  and responses consolidated
- CBER: lead when tests required by FDA for use in blood banks and plasma centers

##  Harmonization Effort Objectives 

- Need for transparency in decision making
- Greater predictability and consistency of decisions
- New technology/new uses of products is challenging the old Intercenter Agreement

##   Interactions/Information Sharing: 

- Scientific knowledge ideas exchange.
- Guidance documents, CLSI Standards committees
- CLIA waiver process
- Review consults
- Joint product reviews
- Post-market product performance issues

## Scientific Knowledge / Ideas Exchange 

- Pharmacogenomics/Genetic testing
- Weekly meetings of diverse inter-center team
- Attendance at sponsor Pre-IDE presentations
- Joint training seminars on general topics /analysis
- Viral Hepatitis – HBV Diversity
- Ability of current tests to detect HBV genotypes / mutants
- Malaria  and  TSE working groups
- Currently organizing a malaria workshop
- Experience with OTC devices
- Joint working group to develop OTC claim study design
- Presentation by CDRH at BPAC
- Annual CBER/CDRH Best Practices Workshop
- Topics such as “Migration Studies” discussed

## Guidance Documents 

- Both centers recommend use of CSLI standards and publish joint guidance docs
- Published:
- 	 "Pharmacogenetic Tests and Genetic Tests for Heritable 	    	Markers“ 2/2006
- Under Review:
- 		”Guidance on Informed Consent for *In Vitro Diagnostic *Device 	Studies Using Leftover Human Specimens that are Not 	Individually Identifiable”
-  		“*In Vitro* Diagnostic (IVD) Device Studies“
- Future Topics:
- 		“ Migration-Studies”
- 		" The PMA Supplement Decision Making Process"

## Guidance Documents (Cont)

- CBER specific guidance docs
- _[http://www.fda.gov/cber/dep/despubs.htm](http://www.fda.gov/cber/dep/despubs.htm)__                                                                     _
- _[http://www.fda.gov/cber/blood/bldguid.htm](http://www.fda.gov/cber/blood/bldguid.htm)_
- CDRH specific guidance docs
- _[http://www.fda.gov/cdrh/oivd/guidance](http://www.fda.gov/cdrh/oivd/guidance)_

## CLIA Categorization and Waiver Review 

- OIVD/CDRH responsible for CLIA Waiver Process
- CBER lead for HIV rapid test PMA approval
- CDRH lead review for  CLIA Waiver

## Consult  Reviews     

- Instrument Software/Hardware
- West Nile/Malaria/HIV/HCV /HBV etc. PMAs, 510(k), Pre-IDEs screening or diagnostic claims
- Tissue perfusion/oximetry/hematocrit devices
- In-vivo/in-vitro cross over studies
- Humoral response to MTB
- Bacterial platelet contamination..Blood culture systems
- Flow Cytometry devices

##  Coordinated Joint Reviews 

- Hepatitis/HIV tests on same platform
- Syphilis test

## Post-market Compliance Issues              

- Close collaboration between OIVD/CBER compliance Staff / Patient Safety Team MDR liaison
- Common manufacturing site changes---joint discussions with sponsor
- FDA or sponsor initiated recalls - common instrument/software/reagent
- Maltose IV solutions (CBER) interference with glucose meter performance (OIVD/CDRH)

## Summary 

- CBER/CDRH will continue to search for opportunities to harmonize and promote processes leading to a consistency of decisions through collaborative interactions
- Questions?