Errors in Mammography Final Regs

["Tupin, Edward A. 301-827-1230 Fax 594-4760" <EAT@CDRH.FDA.GOV>]

Radsafers:

The Federal Register (FR) publication on Tuesday, October 28, 1997 of 
"21 CFR Parts 16 and 900 Quality Mammography Standards; Final Rule"  
contains multiple errors.  The significant ones are incorrect dates for 
various items to go into effect and the showing of only plus (+) signs 
where plus/minus (+) should be. The mainly occur in the Quality 
Assurance [21 CFR 900.12(b)] and Equipment Standards [21 CFR 900.12(e)]. 
The FR pages are 55984 - 55992.

Effective Date errors also occur in the preamble (analysis of comments).

The GPO and FDA web versions posted as of this writing (11:00 A.M. EST, 
Nov 4, 1997) are incorrect.

The Federal Register will publish corrections soon.  It is also expected 
that the corrected actual regulations will be republished (21 CFR 900).

I will let you know when the corrected material is available.

The preceeding is the personal commentary of the author and does not 
represent official position of the Department of Health and Human 
Services or the Food and Drug Administration.

Ed Tupin
RSO, Center for Devices and Radiological Health
Food and Drug Administration
EAT@cdrh.fda.gov
(301) 827-1230
Fax:  (301) 594-4760