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December 9, 2022

A U.S. device manufacturer has been selling an interventional Class II medical device in the market for clinical use in cardiac interventional procedures.

A U.S. device manufacturer has been selling an interventional Class II medical device in the market for clinical use in cardiac interventional procedures. This device is manufactured with primarily polymeric (proprietary formulation) materials. The device manufacturer does not manufacture any other device in their portfolio using the same materials as this interventional device. A hospital which purchases the device since past 3 months, and notified an issue with the product packaging. This device is sterile, and intended for single use only. The device is packaged in a medical grade Tyvek pouch (sterile barrier), and a box carton. The packaged product has been sterilized by the same sterilizer since its launch in the market. The device manufacturer is considering the packaging material change.

Within the scope of Quality Systems Regulations (QSR), how should this issue be assessed for finding a solution?

What would be an appropriate solution for this scenario (complaint issue from hospital)? Determine a regulatory pathway to resolve this issue?

Case 2:

A U.S. manufacturer wants to change coating material of an invasive, sterile and globally marketed medical device. the device is used in procedures for <24 hrs. How should the manufacturer develop a strategy which leads to no regulatory impact to the device?

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