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1123 RESULTS FOUND
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No. FDA-2018-D-1775: Coronary, Peripheral, and Neurovascular Guidewires-Performance Tests and Recommended Labeling; Draft Guidance for Industry and Food and Drug Administration Staff; Availability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Intravacuolar Catheters, Wires, and Delivery Systems with Lubricious Coatings-Labeling Considerations-Draft Guidance for Industry and Food and Drug Administration Staff; Availability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AdvaMed Comments on Docket No. FDA–2014–D–0223: Humanitarian Device Exemption Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability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No. FDA–2018–D–1774: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, Draft Guidance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 Board
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
GMTA General Assembly
July 30, 2018 |
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Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence Through Performance Criteria; Draft Guidance for Industry and Food and Drug Administration Staff; Availability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
RFI on Facilitation of Public-Private Dialogue to Increase Innovation and Investment in the Healthcare Sector
July 3, 2018 | Letter
Software in Medical Devices: Regulations, Guidance, Standards and Terminology; Planning (Module 1)
June 29, 2018 | Presentation
Software in Medical Devices: Device Software Development and Validation (Module 2)
June 29, 2018 | Presentation
Software in Medical Devices: Software Risk Management (Module 3)
June 29, 2018 | Presentation
Software in Medical Devices: Off the Shelf Software (OTS); Cybersecurity (Module 4)
June 29, 2018 | Presentation
AdvaMed Comments on Docket No. FDA-2018-N-1910: Development of 21st Century Cures Act Section 3060 Required Report: Request for Input
June 28, 2018 | Comments
AdvaMed Comments on Docket No. FDA- 2018-D-1339: Multiple Function Device Products: Policy and Considerations; Draft Guidance for Industry and Food and Drug Administration Staff
June 26, 2018 | Comments

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