Draft Guidance for Industry and FDA Staff; Total Product Life Cycle: Infusion Pump–Premarket Notification [510(k)] Submissions

[Federal Register Volume 78, Number 52 (Monday, March 18, 2013)] [Notices] [Pages 16676-16678] | Regulatory Doctor

From the Federal Register Online via the Government Printing Office [www.gpo.gov]

[FR Doc No: 2013-06128]

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———————————————————————–

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0194]

Agency Information Collection Activities; Proposed Collection;

Comment Request; Draft Guidance for Industry and FDA Staff; Total

Product Life Cycle: Infusion Pump–Premarket Notification [510(k)]

Submissions

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on "Guidance for Industry and FDA Staff; 
Total Product Life Cycle: Infusion Pump--Premarket Notification 
[510(k)] Submissions." [Emphasis added]

via Federal Register, Volume 78 Issue 52 (Monday, March 18, 2013).

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