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AdvaMed Comments on Review and Update of Device Establishment Inspection Processes and Standards - June 2019
July 8, 2019 | Comments
AdvaMed Comments on Review and Update of Device Establishment Inspection Processes and Standards - May 2019
July 8, 2019 | Comments
AdvaMed Comments on Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
July 8, 2019 | Comments
AdvaMed Comments on Software Precertification Pilot Program
July 8, 2019 | Comments
AdvaMed Comments on Nonbinding Feedback After Certain Food and Drug Administration Inspections of Device Establishments
July 8, 2019 | Comments
Conference agenda
July 2, 2019 | Agenda
Hotel Recommendation Compliance
July 2, 2019 | Summary
AdvaMed Comments on Public Docket List of Patient Preference-Sensitive Priorities
July 1, 2019 | Comments
AdvaMed Comments on Proposed Rule: Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-Ray, Laser and Ultrasonic Products
July 1, 2019 | Comments
MedTech Compliance 101
June 26, 2019 | Agenda
Investigational Device Exemption (IDE) Submissions Workshop Agenda
June 26, 2019 | Agenda
PMA Submissions Workshop Agenda – Fall 2019
June 26, 2019 | Agenda
MedTech Compliance 201 – A Deeper Dive into Compliance Complexities Agenda
June 25, 2019 | Agenda
510(k) Submissions Workshop Agenda – Fall 2019
June 25, 2019 | Agenda
AdvaMed Comments Regarding FDA-2019-D-1261
June 18, 2019 | Comments
AdvaMed Principles on Reprocessing of Single Use Devices
June 13, 2019 | Guidance
Letter to AMA
June 10, 2019 | Letter
Letter to Amb Lighthizer - Mexico Tariffs
June 7, 2019 |
Clinical Evaluation Comments on Three IMDRF Documents
June 5, 2019 |
AdvaMed Accel University Technology transfer Best Practices Guide – Executive Summary
May 10, 2019 |
New York Times redline May 4, 2019
May 9, 2019 |
May 8, 2019 Letter to HHS re: AKS Safe Harbors for Value-Based Arrangements
May 8, 2019 | Letter
Successful Industry-Academia Partnership Case Studies
May 7, 2019 |
Request for Comments on Modernizing FDA’s 510(k) Program
May 2, 2019 | Letter
Hydrochloric Acid Production Residual Risk and Technology Review
April 30, 2019 | Letter

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