Get Mqsa Facility Certification Extension Requirements For Hologic ... - Fda

Filling out the MQSA Facility Certification Extension Requirements for Hologic is an essential process for facilities wanting to extend their certification for Digital Breast Tomosynthesis. This guide will provide you with clear, step-by-step instructions to help you complete the form accurately and efficiently online.

Follow the steps to fill out the form effectively.

1. Click the ‘Get Form’ button to access the form and open it in your preferred editing tool.
2. Provide facility status information, including the facility name, FDA facility ID number, and FDA certificate expiration date. Ensure that all details are accurate.
3. List the current accreditation body for the 2D unit along with its expiration date. Include the contact person's information, such as title, telephone, fax, and email.
4. Fill in the facility address and the name of the facility owner to ensure proper identification.
5. Identify the DBT unit by providing its manufacturer, model, year of manufacture, and serial number.
6. If applicable, provide identification details for the DBT digital image receptor, including the receptor manufacturer, model, year of manufacture, and serial number.
7. Identify the printer used for hard copy interpretation by listing its manufacturer, model, year of manufacture, and serial number.
8. If your facility utilizes a soft copy display, provide details for the final interpretation review monitor.
9. Complete the phantom identification section by listing the phantom manufacturer and model.
10. Provide information about personnel qualifications, including the names of interpreting physicians and their training qualifications.
11. Include a detailed report of the Mammography Equipment Evaluation, ensuring compliance with specified MQSA requirements.
12. Finalize the document by signing off as the lead interpreting physician, ensuring all provided information is accurate and complete.
13. Once completed, save your changes, and download, print, or share the form as necessary.

Take the next step toward completing your certification by filling out the MQSA Facility Certification Extension Requirements online today.