Medical Devices; Pediatric Uses of Devices: Requirement for Submission of Information on Pediatric Subpopulations that Suffer from a Disease or Condition that a Device is Intended to Treat, Diagnose, or Cure

Document ID: FDA-2009-N-0458-0011
Document Type: Proposed Rule
Agency: Food And Drug Administration
Topics: Administrative Practices and Procedures, Confidential Business Information, Medical Devices, Medical Research, Reporting and Recordkeeping Requirements
Federal Register Number: 2013-03647
CFR Citation: 21 CFR Part 814
View Document:

Details Information

Document Subtype:	Supplemental Notice of Proposed Rulemaking (SNPRM)
Received Date:	February 19 2013, at 12:00 AM Eastern Standard Time
Start-End Page:	11612 - 11617
Page Count:	6
Comment Start Date:	February 19 2013, at 12:00 AM Eastern Standard Time
Comment Due Date:	April 22 2013, at 11:59 PM Eastern Standard Time

Total: 4

Michael Cejnar - Comment
Posted: 04/04/2013 ID: FDA-2009-N-0458-0012

Comment Period Closed
Apr 22,2013 11:59 PM ET

Advanced Medical Technology Association (AdvaMed) - Comment
Posted: 04/26/2013 ID: FDA-2009-N-0458-0013

Comment Period Closed
Apr 22,2013 11:59 PM ET

American Academy of Pediatrics, Elizabeth Glaser Pediatric AIDS Foundation - Comment
Posted: 04/26/2013 ID: FDA-2009-N-0458-0015

Comment Period Closed
Apr 22,2013 11:59 PM ET

Cook Group, Inc. - Comment
Posted: 04/26/2013 ID: FDA-2009-N-0458-0014

Comment Period Closed
Apr 22,2013 11:59 PM ET