Progress in Data Quality, Participation, 

and Transparency at FDA
 

Center for Devices and Radiological Health
 

(CDRH)
 

Kathryn (Katie) O’Callaghan
 

February 29, 2016
 
 

Outline 

• 2013 FDASIA 907 Report: 

>> CDRH findings & identified areas for improvement 

• 2014 FDASIA 907 Action Plan: 

>> CDRH’s commitments & progress 

• Ongoing challenges & need for collaborative 

solutions 

1/14/16 DRA FT 2 
DRA FT 1/6/2016 3
 

FDASIA 907 Timeline
 

FDASIA 

(2012) 

Report 

(2013) 

Action Plan 

(2014) 
 

 

 

What Did We Evaluate 

• Reviewed 37 original PMA
 

applications approved in 2011:
 

–	 46 pivotal clinical studies 

• Demographic data variables: 

–	 Sex, Age, Race, Ethnicity 

• Documents reviewed: 

–	 PMA applications submitted by industry 

–	 Final labeling (industry public info) 

–	 FDA internal review documentation 

–	 SSED: Summaries of Safety &
 

Effectiveness Data (FDA public decision 

summaries)
 

1/14/16 DRA FT	 4 
Representation Varies by 

Disease/Condition 

DRA FT 1/6/2016 5 
 

 

 

Need for Improved Consistency 

in Analysis and Transparency 

Sex • 

• 

• 

88% of PMAs analyzed 

63% presented publicly 

Age 70% of PMAs analyzed 

• 57% presented publicly 

Race &
 • 

Ethnicity
 

27% of PMAs analyzed 

• 16% presented publicly 

1/14/16 DRA FT 6 
FDASIA 907 Timeline
 

FDASIA

(2012) 

Report 

(2013) 

Action Plan 

(2014) 

DRA FT 1/6/2016 7 
1/6/2016 DRA FT 8
 

Action Plan Priorities
 

Transparency 

Participation Quality 
 

 

 

 

Quality 

• CDRH – Completed 

 Final FDA Guidance: Evaluation of Sex-Specific
 

Guidance in Medical Device Clinical Studies
 

 Incorporated recommendations from sex-specific 

guidance (Priority 1.1) 

• Incorporated details of demographic subgroup 

analyses in review templates 

• Launched webinar presentation to external 

stakeholders 

1/14/16 DRA FT 9 
 

 

Quality 

• CDRH – In Progress 

– Draft FDA Guidance: Evaluation & Reporting of 

Age, Race, and Ethnicity Data in Medical Device 

Clinical Studies (Priority 1.1) 

– Staff training on demographic subgroup data 

inclusion, analysis, and communication 

(Priority 1.3) 

1/14/16 DRA FT 10 
 

 

Transparency 

• CDRH – In Progress 

– Explore approaches for public user-friendly ways 

of posting demographic info from medical device 

studies (Priority 3.1) 

– Conduct a study with health care professionals to 

improve usability and understanding of medical 

device labeling, including instructions for use 

(Priority 3.2) 

1/14/16 DRA FT 11 
 

 

 

 

Participation 

• CDRH – Needs Collaboration
 

– Collaborate with industry to ensure appropriate 

use of enrollment criteria in clinical trial protocols 

(Priority 2.2) 

– Explore various ways to communicate to 

demographic subgroups about clinical trial 

participation (Priority 2.4) 

1/14/16 DRA FT 12 
 

 

 

 

CDRH – Related Activities
 

•	 Hired Chief Medical Officer – Pediatrics and Special 

Populations, Dr. Vasum Peiris 

•	 Parallel review with CMS, to streamline decisions 

related to Medicare population 

•	 Home Use & Patient Labeling Initiatives 

•	 Variety of efforts and activities related to pediatrics & 

other special populations, including draft guidance 

on leveraging clinical data for extrapolation to 

pediatric uses of medical devices 

DRA FT 9/9/2015	 13 
 

 

 

 

Needs Collaboration 

• Your input toward collaborative solutions 

– Ensure appropriate use of enrollment criteria in 

clinical trial protocols (Priority 2.2) 

– Explore various ways to communicate to
 

demographic subgroups about clinical trial 

participation (Priority 2.4) 

– Explore approaches for public user-friendly ways of 

posting demographic info from medical device studies 

(Priority 3.1) 

1/14/16 DRA FT 14 
 

 

 

In Summary 

•	 

•	 

•	 

CDRH has completed significant Action Plan 

commitments and is on track for many others
 

Collaborative solutions are needed to overcome longstanding challenges in key areas:
 

–	 

–	 

–	 

Participation – enrollment criteria, diverse participation 

Quality – improving quality of demographic analyses in industry 

submissions and labeling 

Transparency – communicating demographic info in the context 

of overall study results 

Important to keep in mind unique issues related to 

medical devices (manufacturing, clinical study conduct, 

regulatory framework, etc) 

DRA FT 1/6/2016	 15 
1/14/16 DRA FT 16
 

Thank you