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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
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
Perspectives and Good Practices for AI and Continuous Learning Systems in Healthcare
August 24, 2018 | White Paper
AdvaMed Statement on Health Care Innovation Caucus RFI Regarding Value-Based Arrangements
August 15, 2018 | Letter
AdvaMed Comments on Docket No. FDA-2018-D-1775: Coronary, Peripheral, and Neurovascular Guidewires-Performance Tests and Recommended Labeling; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
August 14, 2018 | Comments
AdvaMed Comments on Docket No.FDA-2018-D-1788; Intravacuolar Catheters, Wires, and Delivery Systems with Lubricious Coatings-Labeling Considerations-Draft Guidance for Industry and Food and Drug Administration Staff; Availability
August 14, 2018 | Comments
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
AdvaMed Comments on Docket No. FDA–2014–D–0223: Humanitarian Device Exemption Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
August 10, 2018 | Comments
GMTA Regulatory Committee Distribution
August 8, 2018 |
AdvaMed Comments on Docket No. FDA–2018–D–1774: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, Draft Guidance
August 1, 2018 | Comments
GMTA General Assembly
July 30, 2018 |
GMTA Board
July 30, 2018 |
GMTA Market Access Subcommittee
July 30, 2018 |
GMTA Regulatory Committee
July 30, 2018 |
Global AdvaMedDx Member List
July 30, 2018 |
AdvaMed Comments on Docket No. FDA-2018-D-1329: Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions
July 30, 2018 | Comments
Clips on House Passage - July 24 & 25
July 25, 2018 |
AdvaMed Comments on Docket No. FDA-2018-N-1315: Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health
July 24, 2018 | Comments
AdvaMed Statement on Ways and Means Health Subcommittee Hearing on Stark Modernization
July 17, 2018 | Statement
AdvaMed Comments on Docket No. FDA-2004-N-0191: Product Jurisdiction
July 12, 2018 | Comments
AdvaMed Comments on Docket No. FDA-2018-D-1387: Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence Through Performance Criteria; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
July 11, 2018 | Comments

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