Question No 21:
A company's competitor is marketing a Class II suture that dissolves during the third week of use. The company's current product has to be removed by a physician. However, a change in weaving configuration gives this product the same dissolving times as the competitor's. What needs to be done for the company to market this new dissolving suture?A. Filing a new 510(k) documenting changes in product instructions for use
B. Submission of changes in a periodic report
C. After reporting clinical studies in an Annual Report
D. After submission of labeling change
Answer: A
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