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gh56 replied to the topic Significant risk vs Non-significant Risk in the forum Clinical Trials for Medical Devices 8 years ago
Hi neb2 from the research i did from this week lecture i found few examples that might help you, there is a lot of them but im just going to provide some of them.
for NSR;
-Digital Mammography [Note: an IDE is required when safety and effectiveness data are collected which will be submitted in support of a marketing application.]
-Electroencephalography (e.g., new recording and analysis methods, enhanced diagnostic capabilities)
-Externally Worn Monitors for Insulin Reactions
-Functional Electrical Neuromuscular Stimulators
-General Biliary Catheters General Urological Catheters (e.g., Foley and diagnostic catheters)
-Wound Dressings, excluding absorbable hemostatic devices and dressings (also excluding Interactive Wound and Burn Dressings)SR
Orthopedics and Restorative:
-Bone Growth Stimulators
-Calcium Tri-Phosphate Hydroxyapatite
-Ceramics Collagen and Bone Morphogenic Protein Meniscus Replacements
-Implantable Prostheses (ligament, tendon, hip, knee, finger)
-Computer Guided Robotic Surgery