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Question: 1 / 400

Which Premarket Approval Application (PMA) supplements are NOT subject to user fee exemption?

Real Time Supplement.

The correct choice relates to the real-time supplement, as these supplements are typically subject to user fees under the FDA’s regulations. In the context of PMA supplements, the majority of them, specifically annual reports and minor changes, often qualify for certain exemptions from user fees. Annual Report Supplements generally provide updates on the ongoing status of an approved PMA without incurring user fees. Similarly, Minor Changes Supplements are used for changes that do not significantly impact the device's safety or effectiveness, and they usually do not trigger user fees.

However, Real Time Supplements, which can request rapid changes or modifications in the production or specifications, are processed with more urgency and are therefore liable for user fees. This highlights the FDA's position on prioritizing resources for the evaluation of submissions that could lead to significant alterations in device functionality or public health implications.

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Annual Report Supplement.

Minor Changes Supplement.

30-Day Notice Supplement.

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