Zdrowie i gospodarka · 3.04.1996
Quality Standards and Certification Requirements for Mammography Facilities; General Facility Requirements
The Food and Drug Administration (FDA) is proposing to amend the facility standards established in the interim regulations implementing the Mammography Quality Standards Act of 1992 (the MQSA). This proposed rule would modify and add to the general requirements for mammography facilities, including requirements for a medical reporting and recordkeeping program, a medical outcomes audit program, special methods for examining individuals with breast implants, a consumer complaint mechanism, and a variance procedure for requesting FDA approval of alternative standards. In addition to the statutory framework and the expertise and research of FDA personnel, the agency is proposing this rule based on advice from the National Mammography Quality Assurance Advisory Committee (NMQAAC) and public comments received in response to the interim regulations. This action is being taken to ensure safe, accurate, and reliable mammography on a nationwide basis. This is the third of five related proposed rules being published concurrently.