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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Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence Through Performance Criteria; Draft Guidance for Industry and Food and Drug Administration Staff; Availability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
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AdvaMed Comments on Docket No. FDA- 2018-D-1339: Multiple Function Device Products: Policy and Considerations; Draft Guidance for Industry and Food and Drug Administration Staff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
AdvaMed Comments on Docket No. FDA-2017-N-4301: Fostering Medical Innovation: A Plan for Digital Health Devices; Software Precertification Pilot Program
June 18, 2018 | Comments
Statement by the President Regarding Trade with China
June 15, 2018 | Statement
AdvaMed Comments On Docket No. FDA-2018-D-0944; Draft Guidance for Industry; Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination
June 15, 2018 | Comments
AdvaMed Comments on Docket No. FDA-2008-N-0424: Postmarketing Safety Reporting for Combination Products
June 14, 2018 | Comments
AdvaMed Comments on Re: Supported Lifetimes Request for Information
June 12, 2018 | Comments
AdvaMed Comments on Re: May 9, 2018, FDA-AdvaMed Discussion of Section 702 of the Food and Drug Administration Reauthorization Act
June 12, 2018 | Letter
AdvaMed Comments on Re: Request for 30-Day Extension of Comment Period for FDA Draft Guidance, “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” Docket No. FDA–2018–D–1774
June 7, 2018 | Comments
Social Media Toolkit: The Role of Diagnostics in Combatting Antibiotic Resistance Video
June 4, 2018 |
AdvaMed Comments on Docket No. FDA-2017-N-4301: Fostering Medical Innovation: A Plan for Digital Health Devices; Software Precertification Pilot Program
May 31, 2018 | Comments
Policy Proposals to Advance Value-Based Health Care
May 29, 2018 | Guidance
Analysis Of Hypothetical Arrangement #1 Under Advamed Proposed Safe Harbors For Value-based Pricing Arrangements And Value-based Warranties
May 29, 2018 |
AdvaMed Comments on Docket No. FDA-2018-N-0235: Orthopaedic Sensing, Measuring, and Advanced Reporting Technology Devices; Public Workshop; Request for Comments
May 24, 2018 | Comments
AdvaMed Comments on Docket No. FDA-2017-N-4180: Voluntary Medical Device Manufacturing and Product Quality Program
May 11, 2018 | Comments
AdvaMed Comments on Docket No. FDA-2017-D-6069: Acceptance Review for De Novo Classification Requests, Draft Guidance for Industry and Food and Drug Administration Staff
May 11, 2018 | Comments
AdvaMed Comments on Docket No. FDA-2017-D-5966: Breakthrough Devices Program: Draft Guidance for Industry and Food and Drug Administration Staff
May 11, 2018 | Comments
GMTA Joint Statement on Global Harmonization of Ethical Business Principles In Medical Technology
May 2, 2018 | Statement
Inter-American Coalition for Business Ethics - Bogota Principles
April 30, 2018 | Guidance

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