FDA holds the line on remanufacturing definitions in newly finalized guidance


Almost three years after the initial draft, the FDA has now finalized guidance describing the differences between medical device “servicing” and “remanufacturing” and each activity’s quality system implications. The new guidance maintains the agency’s existing definitions of remanufacturing and servicing, but adds a new section that provide a high level overview of the medical device regulations – primarily for those “less familiar.”

Medical device regulatory oversight does not end at the point of market access, nor do the manufacturing requirements after distribution.

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