Get the free pma supplement definiton form - fda

As of 11/21/03, Section V of this document titled Bundling Multiple Devices in a Single Application has been superseded by a new guidance document titled: Bundling Multiple Devices or Multiple Indications

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What is pma supplement definition form?

The pma supplement definition form is a document used in the medical device industry to provide additional information or make changes to an existing premarket approval (PMA) application.

Who is required to file pma supplement definition form?

Any manufacturer or sponsor who has received PMA approval for a medical device is required to file a pma supplement definition form if they need to make modifications or provide additional information.

How to fill out pma supplement definition form?

The pma supplement definition form can be filled out by providing the required information and supporting documentation as specified by the relevant regulatory authority. The form usually includes sections for identifying information, details of the modification or additional information, and any supporting data or studies.

What is the purpose of pma supplement definition form?

The purpose of the pma supplement definition form is to allow manufacturers or sponsors to make changes or provide additional information to an existing PMA application without having to submit an entirely new application. This helps streamline the regulatory process and ensures that the FDA or other regulatory authorities have the most up-to-date information on a medical device.

What information must be reported on pma supplement definition form?

The specific information that must be reported on the pma supplement definition form can vary depending on the nature of the modification or additional information being provided. However, it typically includes details such as the purpose of the modification, the supporting evidence or data, and any potential impact on the safety or effectiveness of the medical device.