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 timestamp_utc,session_id,first_name,last_name,question,answer,rating,comment
-2025-09-15T15:52:45.446744+00:00,b11b654e-49cb-4a0d-94d7-3b6f8dc91dd4,Tanha,Patel,How can I submit  a screw used for the knee surgery to FDA and which class of device that will be. ,"[LLM fallback — ungrounded]
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-To submit a screw for FDA clearance or approval, you would need to follow the regulatory pathway outlined by the FDA for medical devices. This typically involves submitting a premarket notification (510(k) application for a Class II device or a pre-market approval application (PMA) for a new Class III device. The classification of a screw depends on its intended use, design, and material. For example, a simple cortical screw may be classified as a Class I device, while a locking screw with unique features or material may be Class II. You should consult with a regulatory affairs expert or the FDAs Division of Industry and Consumer Education (DICE) for guidance. The FDA does not have a specific database for orthopedic implants, but the 513(s) database can be used to search for similar devices. Additionally, you may want to consider working with a notified body for CE marking if you plan to sell in Europe. It is important to note that FDA approval is not required for implantable devices sold in the US, but CE mark is required for sale in Europe and other countries. Consult with a qualified regulatory consultant for more information.",4,Need little more specific response.
+2025-09-15T16:16:44.343417+00:00,6b99b885-a5e0-409e-a441-99f1cafed1ff,Shubh,Laiwala,What is fracture healing?,"Answer: Fracture healing refers to the process by which broken bones regain their structural integrity and functional capacity following an injury. It involves the formation of a callus, which is a temporary structure composed of cartilaginous and bony tissue, followed by the remodeling of this tissue into mature bone. The rate and quality of fractures healing can vary depending on factors such as age, bone health, and surgical intervention. Delayed or non-unions occur when the fractured bone fails to heal properly, often due to infection, poor blood supply, or other complications. Treatment options include immobilization, bone grafing, or surgical interventions like bone transport or bone gapping.",5,