When multiple facilities are involved in the production of a Class III device, which action is unnecessary?

In the context of regulatory submissions for a Class III medical device, understanding the compliance requirements for multiple facilities is critical. When a Class III device is produced across several facilities, each facility involved in the manufacturing process must demonstrate compliance with the Quality System Regulations outlined in 21 CFR 820. This encompasses a comprehensive set of quality management requirements that are essential to ensure product safety and efficacy.

Including a description of manufacturing methods in the PMA (Premarket Approval) submission is crucial because it provides the FDA with a detailed understanding of how the device is produced and ensures that all aspects of the manufacturing process are adequately represented and evaluated.

Authorization for referencing a Device Master File (DMF) is also an important step, as it allows the FDA to access necessary information about the components, materials, and processes used in the device that are stored in the DMF. This can be critical for ensuring device safety and efficacy during the review process.

However, submitting quality system information solely for the design facility is unnecessary when multiple facilities are involved in the production of a Class III device. All manufacturing sites must adhere to the quality system regulations, and quality system information should be submitted for each facility that contributes to the production. Therefore, submitting this information only for one facility does not