Investor Presentaiton
IMDRF
International Medical
Device Regulators Forum
STREAMLINING PREMARKET REVIEW:
CONSIDERATION OF UNCERTAINTY IN BENEFIT-RISK
•
.
uncertainty
DETERMINATIONS
Some degree of uncertainty generally exists
around benefits and risks for regulatory decisions
The regulatory standard is reasonable assurance
of safety and effectiveness - not absolute
assurance
.
Flexible, patient-centric approach
Uncertainty is a critical factor in Benefit-Risk decision making, as described in
our original 2012 B-R framework
• CDRH draft guidance provides details to provide greater scientific rigor in the
consideration of uncertainty in certain premarket decisions
.
• CDRH draft guidance describes circumstances where FDA is more likely to
accept greater uncertainty:
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Breakthrough Devices subject to PMA
PMAs with small patient populations, e.g., pediatric populations
Opportunity to harmonize with other jurisdictions and support the
establishment of a Medical Device Single Review Program
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