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DATE TITLE DEPARTMENT MAIN ISSUE TYPE
6/11/2013 Modifications to be Cleared in Commercial Distribution Public Affairs Device Modification Comments
6/10/2013 Docket No. FDA-2013-D-0168; Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex Technology & Regulatory Affairs Latex Comments
5/23/2013 AdvaMed EGCC Membership Benefits Public Affairs Membership Benefits Fact sheet
5/14/2013 Docket No. FDA-2010-D-0194: Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance for Industry and FDA Staff; Total Product Life Cycle: Infusion Pump„Premarket Notification [510(k)] Submissions; Notice Technology & Regulatory Affairs Infusion Pumps Comments
4/25/2013 ENVI Committee Report Technology & Regulatory Affairs ENVI Committee Regulation
4/25/2013 ENVI Committee Report IVDs Technology & Regulatory Affairs ENVI Report Regulation
4/24/2013 Members of Congress Supporting H.R. 523 Government Affairs Device Tax Fact Sheet
4/24/2013 Senate Committee On Finance: The Trans-Pacific Partnership Finance and Business Services Device Tax Testimony
4/19/2013 Docket No. FDA…2009…N…0458; RIN 0910…AG29: 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 Technology & Regulatory Affairs Pediatric Subpopulations Comments
4/19/2013 Docket No. FDA-2013-D-0117: Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act; Availability Technology & Regulatory Affairs Pediatrics Comments
4/12/2013 AdvaMed's Tax Reform Principles Public Affairs Tax Reform White Paper
4/9/2013 AdvaMed Sunshine Comments on the Final Rule and Data Templates Legal Physician Payments Sunshine Comments
3/29/2013 AdvaMed Comments on Implementation of the Medical Device Excise Tax Provisions of the Affordable Care Act – Comments on the Final Regulations and Notice 2012-77 Legal Device Tax Comments
3/25/2013 The Neurointerventionalist and the AdvaMed Code of Ethics Legal Code of Ethics Guidance
3/21/2013 Docket No. FDA…2010…D…0643: Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Correction Technology & Regulatory Affairs Clinical Investigations Comments
3/18/2013 Docket No. FDA-2012-D-1145; Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products Technology & Regulatory Affairs Enrichment Strategies Comments
3/13/2013 Docket No. FDA…2012…D…1161: Draft Guidance for Industry and Food and Drug Administration Staff: Design Considerations for Devices Intended for Home Use; Availability Technology & Regulatory Affairs Home Use Comments
3/5/2013 AdvaMed Code of Ethics Certification and Logo Supplement Package Legal Code Certification and Logo Package Fact sheet
3/5/2013 AdvaMed Supports Continuing Resolution to Fund Government Operations Public Affairs Medical Devices Letter
3/1/2013 AdvaMed, EucoMed, ABO: The Value of Harmonization Efforts in Blood Device Medical Technology Technology & Regulatory Affairs Device Harmonization White Paper
3/1/2013 Morgan Lewis POD White Paper Legal Medical Device Comments
3/1/2013 The Value of Harmonization Efforts in Blood Device Medical Technology Technology & Regulatory Affairs Blood Sector White Paper
2/28/2013 International Board Committee Presentation: Emerging Markets Global Emerging Markets Presentation
2/25/2013 Staff List by Department President's Office Staff List Administrative
2/7/2013 Docket No. FDA-2012-D-1057; Draft Guidance for Industry and Food and Drug Administration Staff; Highly Multiplexed Microbiological/Medical Countermeasure in Vitro Nucleic Acid Based Diagnostic Devices Technology & Regulatory Affairs Highly Multiplexed Microbiological/Medical Countermeasure in IVDs Comments
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