Question

A company's competitor is marketing a Class II suture which 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 time as the competitor's. When can the company's new suture be marketed?

A. This requires a new 510(k) since significant change in product instructions might
affect efficacy.
B. After submission in a periodic report
C. After reporting clinical studies in an annual report
D. After submission of labeling change

Answer 1

A company that has modified an existing suture to dissolve like its competitor's must submit a new 510(k) notification to the FDA due to changes that could affect safety or efficacy.

Step-by-step explanation:

When a company modifies an existing medical device such as a suture to have significant changes that could affect safety or efficacy, they must submit a new 510(k) notification to the FDA. This is because the change in the product's design—a new weaving configuration that allows the suture to dissolve—could impact how the product works and its performance. The FDA requirements for postmarketing risk management indicate that the company should also continue to monitor the safety and performance of the suture through postmarket surveillance or Phase IV trials. In general, these steps are critical to ensuring the safety and efficacy of medical devices on the market.