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Comments & Testimony

Comments


09/18/08 AdvaMed 's Ex Parte Filing of GE Healthcare Petition ET Docket No. 08-59
09/02/08 AdvaMed's Comments to CMS Proposed Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment Rates for CY 2009 (pdf)
08/29/08 AdvaMed's Comments to CMS Revisions to Payment Policies Under the Physician Fee Schedule for CY 2009 (pdf)
07/24/08     AdvaMed's Comments to FDA's Draft Guidance for Industry on Coronary Drug Eluting Stents-Nonclinical and Clinical Studies (pdf)
06/25/08 AdvaMed's Comments to FDA's Draft Guidance for Industry on Coronary Drug Eluting Stents-Nonclinical and Clinical Studies Companion Document (pdf)
06/13/08 AdvaMed's IPPS Comments to CMS on FY 2009 rates 6-12-08 (pdf)
05/05/08 AdvaMed comments submitted to FDA on the Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (Form 3674) (pdf)
04/21/08 AdvaMed comments to FDA on Draft Guidance for Good Reprint Practices of Medical Journal Articles and Reference Publications  (pdf)
04/04/08 AdvaMed's comments regarding the President's Council of Advisors on Science & Technology (PCAST) Personalized Medicine Study Report  (pdf)
03/17/08 AdvaMed's comments submitted to FDA on Docket No. 2008N-0021; Supplemental Application Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices (pdf)
03/13/08 AdvaMed Testimony before the Institute of Medicine's (IoM) Committee on Conflict of Interest in Medical Research, Education and Practice (pdf)
12/20/07 Draft Report of the Secretary's Advisory Committee on Genetics, Health, and Society: U.S. System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of HHS   (pdf)
10/31/07 AdvaMed Comments on CDASH Package-2  (pdf)
10/22/07 AdvaMed Statement to MedCAC Meeting on CMS Evidentiary Priorities   (pdf)
10/11/2007    AdvaMed's Statement to the Centers for Medicare and Medicaid Services (CMS) and Program Advisory and Oversight Committee (PAOC) Meeting (pdf)
10/09/07 AdvaMed's comments submitted to FDA on Docket No. 2007D-0249 – Draft Guidance for Industry: Preparation of Investigational Device Exemptions and Investigational New Drug Applications for Products Intended to Repair or Replace Knee Cartilage (PDF)
09/20/07 Comments on Clinical Trial Designs for Cardiac Ablation Devices (pdf)
09/11/07 AdvaMed's Supplement comments to Docket 2007D-0083 - Draft Guidance for Industry and Food and Drug Administration Staff, Modifications to Devices Subject to Premarket Approval--The PMA Supplement Decision-Making Process (PDF)
08/27/07    AdvaMed's comments submitted to FDA on Agency Information Collection Activities; Proposed Collection; Comment Request; Pre-Market Approval of Medical Devices (pdf)
07/31/07 AdvaMed's comments submitted to FDA concerning agency's Draft Guidance for Industry and FDA Administration Staff; Modifications to Devices Subject to Premarket Approval--The PMA Supplement Decision-Making Process (pdf)
06/22/07 AdvaMed's Supplement comments to Docket 2007D-0083 submitted to FDA concerning agency's Draft Guidance for Industry and FDA Administration Staff; Modifications to Devices Subject to Premarket Approval--The PMA Supplement Decision-Making Process (pdf)
06/12/07 AdvaMed's Comments to CMS on Proposed Changes to the Hospital Inpatient Payment Systems and FY 2008 Rates  (pdf)
05/21/07 AdvaMed's Comments submitted to FDA concerning agency's Draft Guidance on Procedures for Determining Conflict of Interest and Eligibility for Participating in FDA Advisory Committees (pdf)

04/13/07

 AdvaMed Comments on FDA Draft Guidance on Radio-Frequency Wireless Technology in Medical Devices (pdf)

01/30/07

AdvaMed’s written testimony submitted to the House Ways & Means Committee’s Hearing on Trade & Globalization (pdf)

01/24/07 AdvaMed's Comments to FDA concerning "Guidance for Indsutry and FDA Staff; Annual Reports for Approved Premarket Approval Applications"  (pdf)
01/18/07 AdvaMed's statement to the EPA Science Advisory Board on the Evaluation of the Carcinogenicity of the Ethylene Oxide (EtO ) (pdf)
05/19/06 AdvaMed's Comments to the U.S. Environmental Protection Agency concerning agency's risk assessment for ethylene oxide (pdf)
05/10/06 AdvaMed's comments submitted to FDA concerning agency's Draft Guidance for Industry and FDA Staff: Pharmacogenetic Tests and Genetic Tests for Heritable Markers (pdf)
03/31/06 AdvaMed Response to the World Health Organization (WHO) International Clinical Trials Registry Platform Request for Comments on Delayed Disclosure (pdf)
03/20/06 AdvaMed's responses to FDA request for comments to the draft concept paper on “Postmarket Safety Reporting for Combination Products” (pdf)
03/08/06 AdvaMed's comments on Draft Guidance for Industry and FDA Staff: Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens (pdf)
02/28/06 AdvaMed's comments regarding Public Consultation - Update for units of measurement Council Directive 90/181/EEC
02/28/06 AdvaMed's comments on Consumer-Directed Promotion of Regulated Medicinal Products  (pdf)
01/03/06 AdvaMed's Comments submitted to FDA on Draft Guidance on Collection of Platelets through Automated Methods (pdf)
12/08/05 AdvaMed Letter to World Health Organization (WHO) Urging Device Representation on Clinical Trial Registry Project (pdf)
12/06/05 AdvaMed comments submitted to FDA on Draft Guidance for Industry and Staff –Recommendations on Waiver Applications under Clinical Laboratory Improvement Amendments of 1988 (pdf)
11/14/05 AdvaMed's comments to FDA on Draft Guidance on Procedures for Handling Post-Approval Studies Imposed by PMA Order (pdf)
11/10/05 Comments on FDA Draft Guidance for Industry and FDA staff: Compliance with MDUFMA Act of 2002, as amendedProminent and Conspicuous Mark of Manufacturers on Single Use Devices (pdf)
10/28/05 AdvaMed Comments on FDA Proposed Critical Path Workshop on Developing Prevention Therapies (pdf)
09/20/05 AdvaMed Letter to the Institute of Medicine Requesting Clarification on Clinical Trials Registry Project (pdf)
09/0705 CLIA waiver guidance documentRecommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver ApplicationsDraft Guidance for Industry and FDA Staff (pdf)
08/30/05 Institute of Medicine Agrees to Explicitly Exclude Devices from its Clinical Trials Registry Project (pdf)
08/22/05 AdvaMed's submitted comments on FDA's Emergency Use Authorization of Medical Products Guidance Document (pdf)
07/15/05 AdvaMed's submitted comments on FDA's concept paper on diagnostic testing with a drug or biological therapy (pdf)
07/08/05 AdvaMed's submitted written comments and proposals concerning cross-labeling for combination technologies
Part 1 (pdf)          Part 2 (pdf)
06/16/05 AdvaMed's comments to the Institute of Medicine Committee on Identifying and Preventing Medication Errors (pdf)
05/03/05 AdvaMed files comments on FDA proposed changes to MedWatch Forms” for 2004N-0535, and “AdvaMed files comments on FDA proposed changes to Medical Device Reporting regulation” for 2004N-0527 (pdf)
05/02/05 AdvaMed Comments Submitted to FDA Regarding Evaluation of the Status of Condition of Approval Studies (pdf)
02/25/05 AdvaMed Comments on High NSE Rate and Need to Review Validation Data for All Reprocessed Single-Use Devices (pdf)
01/31/05 AdvaMed letter to CDRH Division of Cardiovascular Devices Concerning Replacement Heart Valve Guidance (pdf)
01/07/05 AdvaMed's Comments to FDA on Agency's Proposed Performance Goals for Premarket Modular Review (pdf)

Testimony

Congressional Correspondence

10/5/05 AdvaMed Supports Legislation to Expand Eligibility for NIH Grants to Small Companies in Letters to Senate, (pdf) House Committees (pdf)

Testimony/Public Statements 

09/17/08 AdvaMed DTC Hearing Written Testimony (pdf)
05/21/08 Testimony of Linwood A. Staub, President, Global V.A.C. ® Therapy, Kinteic Concepts Inc., on behalf of AdvaMed, before the House Small Business Subcommittee on Rural & Urban Entrepreneurship (pdf)
05/06/08 AdvaMed's written testimony submitted to the House Ways & Means Committee, concerning implementation of Medicare's competitive acquisition program for durable medical equipment, prosthetics, orthotics and supplies (DMEPOS)  (pdf)
02/28/08 AdvaMed's Statement to the FDA Risk Communication Advisory Committee (pdf)
02/27/08 AdvaMed's written testimony to the Senate Special Committee on Aging hearing on Physician Payment Sunshine Act   (pdf)
02/13/08 AdvaMed's written testimony to the House Small Business Investigations & Oversight Subcommittee, concerning the Small Business Innovation Research grant program and its role in advancing medical breakthroughs    (pdf) 
11/1/07 AdvaMed's written testimony to the House Small Business Committee concerning free trade agreements  (pdf)
10/31/07 AdvaMed's written testimony to House Small Business Committee's Oversight & Investigations subcommittee on Medicare's Competitive Bidding program   (pdf)
10/04/07 AdvaMed's written testimony to House Ways & Means Subcommittee on Trade & Oversight hearing on import safety (pdf)
06/12/07 AdvaMed's written testimony to the House Energy & Commerce Subcommittee on Health concerning reauthorization of the Medical Device User Fee & Modernization Act, etc .  (pdf)
01/30/07 AdvaMed's written testimony submitted to the House Ways & Means Committee's Hearing on Trade & Globalization (pdf)
09/26/06 AdvaMed's testimony on the Hearing on Food and Drug Administration's Oversight and Regulation of the Reprocessed Single-Use Medical Device Industry (pdf)
07/27/06 AdvaMed's written testimony, submitted for the record, to the House Energy & Commerce Subcommittee on Health, for hearing on “Medicare Physician Payment: How to Build a Payment System that Provides Quality, Efficient Care for Medicare Beneficiaries” (pdf)
04/06/06 AdvaMed's testimony, submitted for the record, for House Ways and Means Subcommittee on Health hearing on Health Care Information Technology (pdf)
03/28/06 AdvaMed's written testimony on Hearing on "Public Health Preparedness in the 21st Century" (pdf)
03/16/06 AdvaMed's written testimony submitted for the record to the Senate Health, Education, Labor and Pensions Committee's hearing on "Enhancing Public Health and medical Preparedness: Reauthorization of Public Health and Bioterrorism Preparedness and Response Act." (pdf)
03/16/06 AdvaMed's written testimony submitted for the record to the House Energy and Commerce Subcommittee on Health's hearing on "Legislative Proposals to Promote Electronic Health Records and a Smarter Health Information System." (pdf)
03/14/06 AdvaMed's written testimony submitted for the record to the Senate Appropriations Subcommittee on Agriculture, Rural Development, FDA and related agencies. (pdf)
02/16/06 AdvaMed's written testimony submitted to the House Appropriations Committee Subcommittee on Agriculture, Rural Development and Food & Drug Administration & Related Agencies, on Bush Adminsitration's FY 2007 Budget Proposal for FDA (pdf)
02/16/06 AdvaMed's written testimony submitted to the Senate Finance Committee's hearing on the Bush Administration's 2006 trade agenda (pdf)
02/15/06 AdvaMed's written testimony submitted for the record, to the House Ways & Means Committee, for hearing on Bush Administration's 2006 Global Trade Agenda (pdf)
01/31/06 AdvaMed's Statement for the Record, Submitted to the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, on Pandemic Flu Preparedness (pdf)
11/17/05 AdvaMed's Testimony before Energy and Commerce Subcommittee on Health Hearing on "Medicare Physician Payment: How to Build a More Efficient Payment System" (pdf)
10/07/05 AdvaMed's Testimony before the House Ways & Means Subcommittee on Health hearing on gainsharing. (pdf)
09/29/05 AdvaMed's written statement submitted for the record to the House Ways & Means Committee's Subcommittee on Health, on Medicare Value-Based Purchasing for Physicians' Services Act of 2005 (pdf)
09/29/05 Testimony delivered by Stephen MacMillan President and CEO, Stryker Corporation, on behalf of AdvaMed, before the Senate Foreign Relations Committee's Subcommittee on East Asian and Pacific Affairs, on U.S.-Japanese Relations (pdf)
09/28/05 Testimony delivered by Michael Mussallem, CEO, Edwards Lifesciences Corporation on behalf of AdvaMed, before the House Ways & Means Committee Subcommittee on Trade, on U.S.-Japanese Economic and Trade Relations (pdf)
07/27/05 AdvaMed's Statement for the Record, as Submitted to the House Ways & Means Committee Subcommittee on Health's hearing on health information technology (pdf)
07/20/05 AdvaMed's Written Testimony on House Ways & Means Subcommittee on Health's Hearing on "Value-Based Purchasing for Physicians Under Medicare" (pdf)
06/30/05 AdvaMed's testimony on health information technology submitted for the record to the Senate Commerce, Science, and Transportation Committee's Subcommittee on Technology, Innovation, and Competitiveness (pdf)
06/23/05 AdvaMed's Written Testimony Submitted to the Senate Finance Committee's hearing on US-China Economic Relations (pdf)
06/09/05 AdvaMed's written testimony, submitted for the record to Senate Health, Education, Labor & Pensions Subcommittee on Medical Countermeasures (pdf)
05/11/05 AdvaMed's written testimony, submitted for the record to the Senate Health, Education, Labor, & Pensions Subcommittee on Bioterrorism and Public Health Preparedness Hearing (pdf)
04/21/05 AdvaMed's written testimony submitted for the record to the House Ways and Means Committee, on U.S.-Dominican Republic-Central American Free Trade Agreement (pdf)
04/13/05 AdvaMed's written testimony submitted for the record to the Senate Finance Committee for hearing on U.S.-Dominican Republic-Central American Free Trade Agreement (pdf)