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AdvaMed 2019-2021 Committee and Board Chairs
March 26, 2019 |
Medical Device Tax: Claims vs. Facts
March 12, 2019 | Fact Sheet
Re: Docket No. FDA-2013-D-1445; Draft Guidance for Industry and FDA Staff on Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use
February 28, 2019 |
Re: Docket No. FDA-2013-D-1446; Draft Guidance for Industry and FDA Staff on SelfMonitoring Blood Glucose Test Systems for Over-the-Counter Use
February 28, 2019 |
Re: Docket No. FDA-2017-D-5570; Draft Guidance on Select Updates for Recommendations for CLIA of 1988 Waiver Applications for Manufacturers of IVD Devices
February 27, 2019 |
Re: Docket No. FDA-2017-D-5625; Draft Guidance on Recommendations for Dual 510(k) and CLIA Waiver by Application Studies
February 27, 2019 |
Docket No. FDA-2018-N-3741: Request for Comments on Medical Device Servicing and Remanufacturing Activities; Public Workshop Docket No. FDA-2018-N-3741-0001: White Paper: Evaluating Whether Activities are Servicing or Remanufacturing
February 26, 2019 |
AdvaMedDx VALID Act Comments Overview
February 15, 2019 |
AdvaMedDx VALID ACT Comments
February 15, 2019 | Comments
Docket No. FDA-2018-N-2727; RIN 0910-AH52: Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations
February 13, 2019 | Comments
Cosponsor the Protect Medical Innovation Act of 2019
February 13, 2019 |
University Technology Transfer Best Practices Guide
February 12, 2019 | White Paper
Docket No. FDA-2018-D-3380-0001: Developing and Labeling In Vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products; Draft Guidance for Industry; Availability
February 5, 2019 | Comments
AdvaMed Proposed Legislation - January 25, 2019
January 25, 2019 |
AdvaMed Comments on Licensing Requirements for Implantable Medical Devices Manufactured by 3D Printing; Draft Guidance
January 8, 2019 | Comments
Fact Check: Washington Post - Jeanne Lenzer and Shannon - The FDA is Still Letting Doctors Implant Untested Devices into Our Bodies
January 4, 2019 |
Memo on Medical Technology Artificial Intelligence (AI) in China
January 1, 2019 | White Paper
AdvaMed Comments on Docket No. FDA-2008-D-0180 Coronary Drug Eluting Stents Nonclinical and Clinical Studies
December 21, 2018 | Comments
AdvaMed Comments on Docket No. FDA-2018-N-3519: Collaborative Communities Toolkit
December 17, 2018 | Comments
AdvaMed Comments on Docket No. FDA-2016-D-2565
December 13, 2018 | Comments
AdvaMed Comments on Docket No: FDA-2018-N-4171: PEAC Discussion Document 2018 – Patient Engagement in Medical Device Clinical Trials
December 12, 2018 | Comments
AdvaMed U.S. Code of Ethics (Final) - Eff. Jan 1 2020
December 11, 2018 | Guidance
Overview - AdvaMed U.S. Code of Ethics
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

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