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Regulatory: Page 302
National Mammography Quality Assurance Advisory Committee Meeting
To provide advice and recommendations to the agency on FDA's regulatory issues.
November 30, 1999
GE files PMA for new digital mammography unit
By
Brian Casey
CHICAGO - GE Medical Systems announced at this week’s RSNA meeting that it has already filed a premarket approval (PMA) application for its Senographe 2000D full-field digital mammography system.
November 28, 1999
New FDA Draft Guidance Document
Issued October 8, 1999
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Guidance on Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems."
October 8, 1999
Susan Alpert, Ph.D., M.D.,Named CFSPAN Director of Food Safety
Posted October 4, 1999
FDA's Center for Food Safety and Applied Nutrition (CFSAN) today announced the appointment of Susan Alpert, Ph.D., M.D., as the Center's Director for Food Safety.
October 7, 1999
Quality Mammography Standards - Delay of Effective Date
Posted October 1, 1999
The Food and Drug Administration (FDA) published a direct final rule in the Federal Register of June 17, 1999 (64 FR 32404). The document notified the public of FDA's intention to amend the regulations that govern mammography quality standards to
September 30, 1999
CMS delays NPI registry data
The Centers for Medicare and Medicaid Services (CMS) plans to once again delay the distribution of data from the National Plan and Provider Enumeration System (NPPES).
December 31, 1998
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