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analytics/feedback.csv

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 timestamp_utc,session_id,first_name,last_name,question,answer,rating,comment
-2025-09-15T15:45:27.570321+00:00,ab04a1ad-f5f4-48db-a614-ff86d1a5b8c8,Maciej,Gusciora,is there anti fibrotic approved for tendinopathy?,"[LLM fallback — ungrounded]
+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]
 
-There is currently no approved anti-fibrotic medication specifically for the treatment of tendinitis or tendinopathy. However, some drugs used off-label, such as pirfenidone and losartan, have shown potential benefits in reducing tendon scarring and inflammation. These medications are not FDA-approved for this indication, and their use should be based on individualized clinical judgment. The primary treatment for tendon injuries and tendinpathy remains rest, physical therapy, and surgery when necessary.",4,
+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.