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Case study: A smart benefit-risk strategy for market entry via the De Novo pathway
Lessons learned from a smart strategy to demonstrate safety and effectiveness of a novel software device through evidence-based benefit-risk…
 • 
Ritam Priya
 and 
Naveen Agarwal, Ph.D.
Case study: Neither a SaMD, nor a SiMD; maybe a SaMDA?
A mobile medical app crashing can cause a life-threatening emergency and send you to the hospital. It seems to have fallen through a crack in the…
 • 
Naveen Agarwal, Ph.D.
1
AI in MedTech #1: IDx-DR retinal software for early screening of diabetic retinopathy
A case study to illustrate benefit-risk assessment for an innovative AI-based screening device for early detection of diabetic retinopathy.
 • 
Naveen Agarwal, Ph.D.
2
QMSR is coming. Are you ready?
FDA is expected to finalize the proposed Quality Management System Regulation in 2024. The revised regulation adds a heavy emphasis on risk in alignment…
 • 
Naveen Agarwal, Ph.D.
Case Study: When silent changes in one device cause incompatibility with another
An uncontrolled change in syringe dimensions caused compatibility issues with an infusion pump resulting in overdose, underdose, delay in therapy and…
 • 
Naveen Agarwal, Ph.D.
4
Case Study: When benefit-risk falls below expectations despite solid clinical data
To be judged as safe and effective by regulatory authorities, benefits of a medical device must outweigh risk, and must provide clinically significant…
 • 
Naveen Agarwal, Ph.D.
Case study - when miscalculating risk leads to a warning letter
How a manufacturer of an ambulatory cardiac monitoring system got a warning letter from the FDA due to a simple calculation error.
 • 
Naveen Agarwal, Ph.D.
Case study: Using post-market data to evaluate changes in risk level
How you can estimate P1 and P2 from reported adverse events to estimate the probability of harm and monitor changes in risk levels.
 • 
Naveen Agarwal, Ph.D.
Case Study - Lessons from an FDA warning letter
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