Search results
Results from the WOW.Com Content Network
Under the law, all mammography facilities must: 1) be accredited by an FDA-approved accreditation body, 2) be certified by FDA, or its State, as meeting the standards, 3) undergo an annual MQSA inspection, and 4) prominently display the certificate issued by the agency.
The legislation Texas HB 2102 requires that a certified mammography facility approved by the FDA or a certification agency approved by the FDA, shall upon completion of the mammogram provide to the patient educational materials about how dense breast tissue is prevalent and normal, and how it can reduce the efficacy of traditional screening tools such as mammograms.
The 1992 Mammography Quality Standards Act (MQSA) required all mammography facilities to be accredited as meeting quality standards. In 1997, the Food and Drug Administration Modernization Act (FDAMA) created the “least burdensome” approach to encourage FDA staff and industry to use the minimum amount of information to address regulatory ...
Commission on Accreditation of Rehabilitation Facilities (CARF) Community Health Accreditation Program(CHAP) DNV GL Healthcare; Foundation for the Accreditation of Cellular Therapy (FACT) [4] Global Healthcare Accreditation (GHA) [5] Healthcare Facilities Accreditation Program (HFAP) Healthcare Quality Association on Accreditation (HQAA)
As of March 1, 2010, 62% of facilities in the United States and its territories have at least one FFDM unit. [47] (The FDA includes computed radiography units in this figure. [48]) Tomosynthesis, otherwise known as 3D mammography, was first introduced in clinical trials in 2008 and has been Medicare-approved in the United States since 2015. As ...
For instance, a regulatory agency (such as CE or FDA) may ensure that a product has been validated for general use before approval. An individual laboratory that introduces such an approved medical device may then not need to perform their own validation, but generally still need to perform verification to ensure that the device works correctly ...
Clinical laboratories in the US that perform high complexity testing require a high complexity laboratory director (HCLD) that has earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and be certified and continue to be certified by a board approved by HHS.
Australian Council on Healthcare Standards International (ACHSI) [7] Australian General Practice Accreditation Limited (AGPAL) [8] Australian Commission on Safety and Quality in Health Care (ACSQHC) [9] uses standards developed by the National Safety and Quality Health Service Standards (NSQHS Standards) [10]