MQSA Updates Quick Reference Guide

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Mammologix, powered by I/O Trak, Inc., proudly presented its MQSA Updates Quick Reference Guide.


This comprehensive guide is designed to help mammography facilities navigate the recent amendments to the Mammography Quality Standards Act (MQSA) regulations, as authorized by the FDA and set to become effective on September 10, 2024.


§ 900 Revisions Checklist for Policy/Procedure Updates

Introduction Page 2
Disclaimer Page 3
§ 900 Revisions Checklist for Policy/Procedure Updates Page 4
§ 900.2 Definitions Page 5

§ 900.4 Standards for Accreditations Bodies

  •  Revise paragraphs (a)(6) and (f)(1)(ii)(B)
Page 8

§ 900.11 Requirements for Certifications

  • Revise paragraph (c)(4)
Page 10

§ 900.12 Quality Standards

  • Revise paragraph (a)(4);
  • Add paragraphs (b)(2)(i) and (ii);
  • Revise paragraph (b)(11);
  • Add paragraph (b)(16);
  • Revise paragraphs (c)(1) and (2), (c)(3)(ii), (c)(4), and (f)(1);
  • Add paragraph (f)(4)
  • Revise paragraph (j)
Page 12

§ 900.14 Suspension or Revocation of Certificates

  • Revise paragraphs (a) introductory text and (a)(3), (5), and (6)
  • Add paragraph (a)(7) 
Page 44

§ 900.15 Appeals of Adverse Accreditation or Reaccreditation Decisions that Preclude Certification or Recertification

  • Revise paragraph (d)(1)
Page 47

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