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Estimates of Medical Device Spending in the United States - November 2018
November 15, 2018 | Study
AdvaMed Comments on Docket No. FDA-2018-N-1794: FDA Report on the Quality, Safety and Effectiveness of Servicing of Medical Devices in Accordance with Section 710 of the Food and Drug Administration Reauthorization Act of 2017 (FDARA)
November 12, 2018 | Comments
Docket No. FDA-2018-D-0787: Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank
November 9, 2018 | Comments
FDA Advisory Committee Meetings and the Role of the Industry Representative Questions And Answers
October 30, 2018 | Guidance
AdvaMed Comments on Docket No. FDA-2018-N-0628: Medical Device Submissions: Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies To Be Allowed in Electronic Format
October 29, 2018 | Comments
AdvaMed Statement Re: OIG–0803–N: Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP
October 26, 2018 | Letter
Physician Service Market Analysis Report
October 22, 2018 |
AdvaMed Comments on Docket No. FDA–2018–D–2896: Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, and Biological Products for Treatment; Draft Guidance for Industry; Availability
October 19, 2018 | Comments
AdvaMed Comments on Docket No. FDA-2018-N-3066: Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments
October 16, 2018 | Comments
2019 AdvaMed Code Certification and Logo Supplement Package
October 15, 2018 | Administrative
AdvaMed Comments on Docket No. FDA-2018-D-2310: Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices; Draft Guidance for Industry and Food and Drug Administration Staff
October 15, 2018 | Comments
Medical Device Follow Up Letter
October 11, 2018 | Letter
Burningham v Wright Medical - Amici Brief
October 8, 2018 |
Quality Culture Playbook
October 8, 2018 | Presentation
Letter to Congress Urging Action Signed by 17 Organizations
October 1, 2018 | Letter
Celebrating Diversity At The MedTech Conference
September 21, 2018 | Fact Sheet
AdvaMed Comments on Docket No. FDA-2018-N-0404: Pediatric Medical Device Development Public Meeting; Request for Public Comments
September 14, 2018 | Comments
AdvaMed Statement on Energy and Commerce Health Subcommittee Hearing on VBHC Barriers
September 13, 2018 | Statement
AdvaMed Comments on Docket No. FDA-2018-N-1621: Patient-Focused Drug Development for Chronic Pain; Notice of Public Meeting; Request for Comments
September 10, 2018 | Comments
AdvaMedDx Comments on FDA Technical Assistance (TA) on Diagnostic Accuracy and Innovation Act (DAIA) House Discussion Draft
August 27, 2018 | Comments
Perspectives and Good Practices for AI and Continuous Learning Systems in Healthcare
August 24, 2018 | White Paper
GmLP Checklist
August 24, 2018 | Guidance
AdvaMed Comments on Re:CMS–1720–NC: Request for Information Regarding the Physician Self-Referral Law
August 24, 2018 | Comments
AdvaMed Statement on Health Care Innovation Caucus RFI Regarding Value-Based Arrangements
August 15, 2018 | Letter
AdvaMed Comments on Docket No. FDA-2018-N-2065: Alternative or Streamlined Mechanisms for Complying with the Current Good Manufacturing Practice Requirements for Combination Products; Proposed List Under the 21st Century Cures Act
August 14, 2018 | Comments

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