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AdvaMed Comments on Docket No. FDA-2017-D-6069: Acceptance Review for De Novo Classification Requests, Draft Guidance for Industry and Food and Drug Administration Staff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AdvaMed Comments on Docket No. FDA-2017-D-5966: Breakthrough Devices Program: Draft Guidance for Industry and Food and Drug Administration Staff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
AdvaMed Comments on WHO Prequalification Financing Model Public Consultation on Fees for In Vitro Diagnostics; Comments on behalf of AdvaMed and MedTech Europe
April 30, 2018 | Comments
AdvaMed Comments on Docket No. FDA–2018–N–0627: Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
April 30, 2018 | Comments
Inter-American Coalition for Business Ethics - Bogota Principles
April 30, 2018 | Guidance
Capitol Hill Showcase Event: Combatting America's Opioid Epidemic with MedTech
April 30, 2018 |
AdvaMed Comments on Docket No. FDA-2016-N-2378; Internal Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health
April 18, 2018 | Comments
The Inter-American Coalition for Business Ethics in the Medical Technology Sector
April 17, 2018 | Summary
Lima Commitment
April 17, 2018 | Statement
UK Pathfinder Program - ABHI Inward Mission - June 2018
April 10, 2018 | Fact Sheet
MedTech Innovator Pediatric Pitch 2018
April 9, 2018 | Agenda
Coverage, Coding and Reimbursement Policies for Medical Technologies
April 9, 2018 | Infographic
AdvaMed Comments On Docket No. FDA-2017-N-4301: Fostering Medical Innovation: A Plan for Digital Health Devices; Software Precertification Pilot Program
April 6, 2018 | Comments
Trade Policy 101 Tutorial for AdvaMed Members
April 2, 2018 | Agenda
AdvaMed Comments On Docket No. FDA-2017-N-6356FDA-2017-D-5570; Draft Guidance on Select Updates for Recommendations for CLIA of 1988 Waiver Applications for Manufacturers of IVD Devices
March 30, 2018 | Comments
AdvaMed Comments On Docket No. FDA-2017-D-5625-0002; Draft Guidance on Recommendations for Dual 510(k) and CLIA Waiver by Application Studies
March 30, 2018 | Comments
FDA Requirements for Medical Technology
March 28, 2018 | Infographic
AdvaMed Comments on Docket No. FDA-2017-D-6765; Draft Guidance for Industry and Food and Drug Administration Staff; Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices
March 21, 2018 | Comments
AdvaMed Comments On Docket No. FDA-2017-N-6356; Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors and Institutional Review Boards; Investigational IVD Used in Clinical Investigations of Therapeutic Products
March 21, 2018 | Comments
AdvaMed Comments on Docket No. FDA-2016-D-3548: Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Draft Guidance for Industry and Food and Drug Administration Staff
March 20, 2018 | Comments
AdvaMed Comments on Re: Input for the Food and Drug Administration’s Consideration in Developing Draft Guidance To Implement Section 702 of the of the Food and Drug Administration Reauthorization Act
March 9, 2018 | Comments
AdvaMed Comments on Docket No. FDA-2017-D-6702: The Least Burdensome Provisions: Concept and Principles
March 9, 2018 | Comments
Use Case: Application of the Medtech Value Assessment Framework to Stereotactic Body Radiation Therapy for Non-Small Cell Lung Cancer (SBRT)
March 8, 2018 |
AdvaMed 2018 AKS Safe Harbor Proposals for Value-Based Arrangements
February 27, 2018 | Letter

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