Stryker Cutting Guide FDA Approval
Honors Capstone Project
1
Advisor(s)
Dr. Gargac
Confirmation
1
Document Type
Paper
Location
ONU McIntosh Center; Ballroom
Start Date
18-4-2023 2:15 PM
End Date
18-4-2023 5:00 PM
Abstract
Medical devices require sufficient testing and documentation to receive US Food and Drug Administration (FDA) approval that they are safe and effective for patients to use. Lower risk medical devices can apply for a premarket notification to prove that the product is similar to existing devices by filling out a Summary of Safety and Effectiveness Data (SSED). Once the SSED is approved, the medical device can be accelerated through the FDA approval process and reach the public sooner. For my capstone group’s designed surgical cutting guide I have written a SSED. I have focused on the potential risks of using the device, creating a testing procedure similar to the FDA’s, and reporting results of testing. If Stryker decides to produce our guide, these documentations will be required in the next steps of FDA approval and bringing the medical device to market.
Recommended Citation
Wernoch, Lacey, "Stryker Cutting Guide FDA Approval" (2023). ONU Student Research Colloquium. 5.
https://digitalcommons.onu.edu/student_research_colloquium/2023/papers/5
Open Access
Available to all.
Stryker Cutting Guide FDA Approval
ONU McIntosh Center; Ballroom
Medical devices require sufficient testing and documentation to receive US Food and Drug Administration (FDA) approval that they are safe and effective for patients to use. Lower risk medical devices can apply for a premarket notification to prove that the product is similar to existing devices by filling out a Summary of Safety and Effectiveness Data (SSED). Once the SSED is approved, the medical device can be accelerated through the FDA approval process and reach the public sooner. For my capstone group’s designed surgical cutting guide I have written a SSED. I have focused on the potential risks of using the device, creating a testing procedure similar to the FDA’s, and reporting results of testing. If Stryker decides to produce our guide, these documentations will be required in the next steps of FDA approval and bringing the medical device to market.