Radiation-Emitting Products

Policy Guidance Help System

Policy Guidance Help System logo

The Policy Guidance Help System was last updated September 9, 2014 

 

The Policy Guidance Help System has useful information for mammography facilities and their personnel. It shows the Food and Drug Administration’s (FDA) current view on the final regulations implementing the Mammography Quality Standards Act (MQSA) (Pub. L.102-539). The FDA uses mandatory language, such as "shall," "must," and "require," when it refers to statutory or regulatory requirements. The FDA uses non-mandatory language, such as "should," "may," "can," and "recommend," when it refers to guidance. Each facility needs to follow the final regulations.

Under its own authority, a State may impose more requirements than those specified under MQSA and its implementing regulations. A facility should check with its State and local authorities about their requirements.

Back to Top Arrow


This system has several main topics:
 

Accreditation and Certification
Additional Mammography Review and Patient Notification
Approved Alternative Standards/Requirements
Alternative Requirements
Breast Implants
Clinical Image Quality
Consumer Complaints
Definitions
Equipment
CMS (Formerly HCFA)
Health Insurance Portability and Accountability Act (HIPAA)
Inspection
Inspector's Questions
Medical Outcomes Audit
Medical Records and Reports
Preparing for MQSA Inspections
Personnel
Quality Assurance

Back to Top Arrow


Topics have subtopics. A subtopic often starts with a citation of the regulation to which it relates. Then, there is a discussion and/or a series of questions and answers offering guidance about how FDA implements the regulation. Some topics end with a list of related topics. To see the contents of a subtopic, click on its title.

If you have comments or questions about the Policy Guidance Help System, please send them via e-mail to MQSAhotline@hcmsllc.com.

Back to Top Arrow


Accreditation and  Certification

Back to Top Arrow


Additional Mammography Review and Patient Notification

Back to Top Arrow


Approved Alternative Standards/Requirements
 

Back to Top Arrow


Alternative Requirements

Back to Top Arrow


Breast Implants

Back to Top Arrow


Clinical Image Quality

Back to Top Arrow


Consumer Complaints

Back to Top Arrow


Definitions

Back to Top Arrow


 Equipment

Back to Top Arrow


CMS (Formerly HCFA)

 Health Insurance Portability and Accountability Act (HIPAA)

 Inspection

General

Back to Top Arrow


Quality Control and Quality Assurance

Back to Top Arrow


Report

STEP

Survey

X-Ray

Back to Top Arrow


Inspector's Questions

Medical Outcomes Audit

Back to Top Arrow


Medical Records and Reports

Preparing for MQSA Inspections

Back to Top Arrow


Personnel
General

Back to Top Arrow


Interpreting Physician

Back to Top Arrow


Medical Physicist

Back to Top Arrow


Radiologic Technologists

Back to Top Arrow


Quality Assurance

Equipment

Back to Top Arrow


General

Back to Top Arrow


Mammography Facility Survey and Medical Physicist Qualification Requirements

Back to Top Arrow


Response to Natural Disasters

Back to Top Arrow


States as Certifiers

Back to Top Arrow


 

Page Last Updated: 09/26/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.