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AdvaMed Comments on Docket No: FDA-2018-N-4171: PEAC Discussion Document 2018 – Patient Engagement in Medical Device Clinical Trials
December 12, 2018 | Comments
Overview - AdvaMed Code of Ethics (Revised for 2020)
December 11, 2018 | Summary
Supporting Public Health and Innovation Through Timely, High Quality Tests: Precertification for Diagnostics
December 7, 2018 |
Humnaitarian Device Exemption (HDE)
December 7, 2018 | Fact Sheet
Advisory Committees
December 7, 2018 | Fact Sheet
Investigational Device Exemption (IDE)
December 7, 2018 | Fact Sheet
Medical Device Classification
December 7, 2018 | Fact Sheet
Patient Groups Urge Congress to Repeal the Medical Device Tax
December 5, 2018 | Letter
Fact Check: NBC News - Medical Device Makers Spend Millions Lobbying To Loosen Regulations In D.C.
December 5, 2018 | Statement
Letter to Congress Urging Repeal of Medical Device Tax
December 5, 2018 | Letter
Docket No. FDA-2012-N-1021; Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2019 Proposed Guidance Development
December 4, 2018 | Comments
AdvaMed Position on ICIJ Medical Device Stories
November 28, 2018 | Statement
AdvaMed Comments on Docket No. FDA-2018-D-3304
November 27, 2018 | Comments
Fact Check: ICIJ - Medical Devices Harm Patients Worldwide As Governments Fail On Safety
November 25, 2018 | Statement
Fact Check: NBC Nightly News with Lester Holt (Transcript)
November 25, 2018 | Statement
Fact Check: NBC News - More Than 80,000 Spinal Cord Stimulator Reports Filed with FDA Over Last Decade
November 25, 2018 | Statement
Fact Check: NBC Nightly News - Thousands of Medical Devices Made in U.S. Are Approved Only For Sale Overseas
November 24, 2018 | Statement
AdvaMed Comments on Docket No. FDA-2018-D-3130: Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions; Draft Guidance for Industry and Food
November 16, 2018 | Comments
Estimates of Medical Device Spending in the United States - November 2018
November 15, 2018 | Study
AdvaMed Comments on Docket No.FDA–2018–D–2936: Recognition and Withdrawal of Voluntary Consensus Standards; Draft Guidance for Industry and Food and Drug Administration Staff
November 13, 2018 | Comments
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

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