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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Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, and Biological Products for Treatment; Draft Guidance for Industry; Availability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FDA-2018-D-2310: Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices; Draft Guidance for Industry and Food and Drug Administration Staff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
AdvaMed Comments on Docket No. FDA-2018-N-0404: Pediatric Medical Device Development Public Meeting; Request for Public Comments
September 14, 2018 | Comments
AdvaMed Statement on Energy and Commerce Health Subcommittee Hearing on VBHC Barriers
September 13, 2018 | Statement
AdvaMed Comments on Docket No. FDA-2018-N-1621: Patient-Focused Drug Development for Chronic Pain; Notice of Public Meeting; Request for Comments
September 10, 2018 | Comments
AdvaMedDx Comments on FDA Technical Assistance (TA) on Diagnostic Accuracy and Innovation Act (DAIA) House Discussion Draft
August 27, 2018 | Comments
Perspectives and Good Practices for AI and Continuous Learning Systems in Healthcare
August 24, 2018 | White Paper
GmLP Checklist
August 24, 2018 | Guidance
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

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