USA/1464
WTO/TBT
US Etats-Unis d'Amérique
  • 03 - Services, Organisation de l'entreprise, Gestion et qualité, Administration, Transport, Sociologie
  • 11 - Technologies de la santé
  • 13 - Environnement, Protection de la santé, Sécurité
2019-06-26
2019-04-11

Mammography quality; Quality (ICS 03.120), Radiation protection (ICS 13.280), Medical sciences and health care facilities in general (ICS 11.020), Medical equipment (ICS 11.040)

Mammography Quality Standards Act (18 page(s), in English)

The Food and Drug Administration (FDA or Agency) is proposing to update the mammography regulations that were issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). We are proposing updates to modernize the regulations by incorporating current science and mammography best practices. These updates would improve the delivery of mammography services by strengthening the communication of healthcare information; allowing for more informed decision making by patients and providers (by requiring facilities to provide them with additional health information); helping to ensure the availability of qualified mammography personnel; bolstering the medical outcomes audit to provide feedback to improve mammography interpretations; modernizing technological aspects of the standards; and adding additional tools to deal with noncompliant facilities.