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Re: MQSA


ON 07 Sep 95  Swilson wrote:
>
>I am trying to obtain a copy of the most up-to-date regulations on the 
>Mammography Quality Standards Act. I have subscribed to the FDA's
>"Mammography Matters" newslist and have from them obtained a copy of 21 
>CFR Part 900 'Interim Rule' for the MQSA (with a cover dated 4/18/95). 
>However there seems to be some difference between the particulars of the 
>interim rule and the actual requirements which inspectors are utilizing.
>
>Can you direct me to an ftp site which contains the current rule, or 
>otherwise point me to the correct person?
>
>Any help would be appreciated.
>

The FDA is to be putting up a WWW home page; but, it is my understanding
that the home page is not up and running.  

Any differences between the regs .... 21CFR900, ACR Mammography Quality
Control Manual 1992 and 1994 and what the inspectors are inspecting should
be reported to the FDA.  The 21CFR900 document address is (from page 67558):


        Charles Showalter
        Center for Devices and Radiological health (HFZ-200)
        5600 Fishers Lane
        Rockville, MD  20857

        Phone:  301-594-3311


        The FDA has published a modification to the 21 Dec 93 regs that
addresses variances.  The "guts" of MQSA is found in the 21 Dec 93 Fed
Register announcement.


JERRY THOMAS



CAPT Jerry A. Thomas,  MSC, USN
Chief Radiological Physics
Department of Radiology/Nuclear Medicine
Uniformed Services University of the Health Sciences
4301 Jones Bridge Road
Bethesda, MD  20814-4799

E-mail:  thomas@bob.usuf2.usuhs.mil
Phone:   (301) 295-3246
Fax:        (301) 295-3893