Drug Device Combination Products (DDC)Drug-device combination products are a class of medical products that combine drugs, biologics, or therapeutic agents with medical devices…Sep 15, 2023Sep 15, 2023
510k Q-Submission / Pre- SubmissionQ-submission is submitted for feedback on the device by formal written request to the FDA by the submitter. The feedback is provided in the…Jun 22, 2022Jun 22, 2022
When 510(k) submission is neededUnless exempted, the 510(k) submission for a medical device is needed in the following scenarios:Jun 1, 2022Jun 1, 2022
510k Syringe needle Introducer.Let me brief how is it possible to get a smooth 510k clearance for SyringeJan 8, 2021Jan 8, 2021
