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AdvaMed's Comments to FDA's Draft Guidance for Industry on Coronary Drug Eluting Stents-Nonclinical and Clinical Studies (pdf) |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AdvaMed's Comments to FDA's Draft Guidance for Industry on Coronary Drug Eluting Stents-Nonclinical and Clinical Studies Companion Document (pdf) |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AdvaMed comments to FDA on Draft Guidance for Good Reprint Practices of Medical Journal Articles and Reference Publications (pdf) |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AdvaMed's comments submitted to FDA on Docket No. 2007D-0249 – Draft Guidance for Industry: Preparation of Investigational Device Exemptions and Investigational New Drug Applications for Products Intended to Repair or Replace Knee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AdvaMed's Supplement comments to Docket 2007D-0083 - Draft Guidance for Industry and Food and Drug Administration Staff, Modifications to Devices Subject to Premarket Approval--The PMA Supplement Decision-Making Process (PDF) |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) |