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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: 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: ICIJ - Medical Devices Harm Patients Worldwide As Governments Fail On Safety
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Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions; Draft Guidance for Industry and Food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AdvaMed Comments on Docket No.FDA–2018–D–2936: Recognition and Withdrawal of Voluntary Consensus Standards; Draft Guidance for Industry and Food and Drug Administration Staff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
Physician Service Market Analysis Report
October 22, 2018 |
AdvaMed Comments on Docket No. FDA–2018–D–2896: Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, and Biological Products for Treatment; Draft Guidance for Industry; Availability
October 19, 2018 | Comments
AdvaMed Comments on Docket No. FDA-2018-N-3066: Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments
October 16, 2018 | Comments
2019 AdvaMed Code Certification and Logo Supplement Package
October 15, 2018 | Administrative
AdvaMed Comments on Docket No. FDA-2018-D-2310: Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices; Draft Guidance for Industry and Food and Drug Administration Staff
October 15, 2018 | Comments
Medical Device Follow Up Letter
October 11, 2018 | Letter
Quality Culture Playbook
October 8, 2018 | Presentation
Burningham v Wright Medical - Amici Brief
October 8, 2018 |
Letter to Congress Urging Action Signed by 17 Organizations
October 1, 2018 | Letter
Celebrating Diversity At The MedTech Conference
September 21, 2018 | Fact Sheet
AdvaMed Comments On Docket No. FDA-2017-N-4301: Fostering Medical Innovation: A Plan For Digital Health Devices; Software Precertification Pilot Program
September 20, 2018 | Comments

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