Federal Register - Software Reclassification (MDDS) - Final Decision by FDA yet?

S

Silvertabb

#1
Hi,

Federal Register / Vol. 73, No. 27 / Friday, February 8, 2008 / Proposed Rules involved proposal rules about below:

21 CFR Part 880 [Docket No. 2007N–0484]

Devices: General Hospital and Personal Use Devices; Reclassification of Medical Device Data System.

Can anyone tell if FDA made any final decision?

Thanks
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
A 'Bump'. Do any of the FDA folks here have any information on the status of 21 CFR Part 880 [Docket No. 2007N–0484] ?
 
W

Watchwait

#4
We have our regulatory attorneys asking this same question regularly. In our last conversation, maybe two months ago, MDDS Final Rule was still targeted for year end publication in the FR. But alas, this appears not to be the case. LATEST information is that two things have been delaying (and may continue to adversely impact) the Final Release of the MDDS classification:

1) Competing legislation. Healthcare, START II, don't ask/don't tell & a plethora of issues being ramrodded through in 11th hour lame-duck sessions. This activity is always at the expense of something else.

2) A subtle yet real leaning towards a greater caution/less risk averse position being touted by FDA. Other recent public pronouncements tend to support this positioning. As MDDS is a down-classification from III to I, this may be an issue.

FYI...there are virtually no CURRENT comments/assessments/projections as to when/if MDDS is destined to become the law of the land.
 
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