Get Completed Field Safety Corrective Action Form

Filling out the Completed Field Safety Corrective Action Form online is a key step in reporting safety concerns related to medical devices. This guide provides users with detailed instructions to complete each section of the form accurately and effectively.

Follow the steps to successfully fill out the form.

1. Click ‘Get Form’ button to obtain the form and open it in the online editor.
2. Complete the Administrative Information section by providing the destination, type of report, date of the report, reference numbers, and name of the coordinating national competent authority.
3. Fill in the Information on Submitter of the Report section, indicating the status of the submitter and any specific role if applicable.
4. In the Manufacturer Information section, enter details about the manufacturer, including name, contact person, address, phone, and email.
5. If applicable, provide details in the Authorised Representative Information section, including their name, address, and contact information.
6. Enter the National Contact Point Information with the relevant details of the contact person for the national agency.
7. Complete the Medical Device Information section, including the class, nomenclature system, commercial name, model number, serial numbers, lot numbers, manufacturing date, and expiration date.
8. Describe the Field Safety Corrective Action by outlining the background information, reason for the FSCA, description and justification of the action, advice on actions taken by users, and progress of FSCA.
9. Attach any additional documents relevant to the FSCA and mention if the FSN status is draft or final.
10. In the comments section, affirm the correctness of the information provided and add any final notes.
11. After completing all sections, save your changes, then download, print, or share the form as needed.

Complete your documents online to ensure accurate safety reporting.