Investor Presentaiton
IMDRF
International Medical
Device Regulators Forum
STREAMLINING PREMARKET REVIEW:
EXPANDED ABBREVIATED 510(K)
• For certain well-understood device types that FDA would
identify, substantial equivalence determinations could be made
based on comparisons to safety and performance criteria
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Criteria: FDA-recognized national and international standards, FDA
final guidance documents, special controls, or a combination
Maintains FDA's clearance standard while providing patients
and healthcare professionals with greater confidence that
devices meet performance standards that reflect the complexity
of more modern products
Can drive innovation of safer devices
Opportunity to harmonize with other jurisdictions and support
the establishment of a Medical Device Single Review Program
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