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What Are the Application Forms for FDA Certification of Medical Devices in the U.S.?
Category：企業(yè)動(dòng)態(tài) Date：2025-01-02 17:12:26 Author: Source:
The application forms required for FDA certification of medical devices in the U.S. depend on the regulatory pathway and the type of device. Here are the key forms used:

The application forms required for FDA certification of medical devices in the U.S. depend on the regulatory pathway and the type of device. Here are the key forms used:

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  1. FDA Form 3514 (Premarket Approval Application - PMA):

    • This form is used for Class III devices that require Premarket Approval (PMA). It includes sections for device description, clinical data, manufacturing information, and labeling. The PMA submission involves extensive documentation to demonstrate safety and efficacy.

  2. FDA Form 2877 (Device Listing and Registration):

    • This form is used for device listing and establishment registration with the FDA. Manufacturers must complete this form to list their devices and register their establishments annually.

  3. FDA Form 510(k) (Premarket Notification):

    • This form is used for Class II devices that require 510(k) premarket notification. It provides information about the device, including its intended use, technological characteristics, and substantial equivalence to a legally marketed device.

  4. FDA Form 3674 (Certification of Compliance with Requirements of Clinical Trials):

    • For clinical trials, this form is used to certify that the device manufacturer has complied with the FDA's clinical trial regulations.

  5. FDA Form 483 (Inspectional Observations):

    • If an FDA inspection is conducted at the manufacturing site, this form may be issued to record observations or deficiencies identified during the inspection. It is not a submission form but is important for ensuring compliance during the approval process.

  6. FDA Form 3515 (Supplement to PMA Application):

    • If a manufacturer needs to make changes to a previously approved PMA device, this form is used to submit a supplement to the original application.

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