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What is pmn supp rel marketing?

PMN Supp Rel Marketing refers to the supplemental reporting requirements associated with premarket notification submissions (510(k)) for medical devices, ensuring that additional marketing information is provided for regulatory review.

Who is required to file pmn supp rel marketing?

Manufacturers and importers of medical devices who have submitted a 510(k) premarket notification are required to file PMN supplementary relative marketing information.

How to fill out pmn supp rel marketing?

Filling out PMN Supp Rel Marketing involves providing specific details about the device, including its intended use, marketing details, and any changes to the device since the original submission, in accordance with provided FDA guidelines.

What is the purpose of pmn supp rel marketing?

The purpose of PMN Supp Rel Marketing is to ensure that the FDA has up-to-date information on the marketing status and changes to medical devices, allowing for better regulatory oversight and public safety.

What information must be reported on pmn supp rel marketing?

Information that must be reported includes device description, intended use, any modifications, clinical data, and marketing practices related to the device.