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Postmarket

 


 

Medical Devices

08/31/04

AdvaMed Comments Submitted to Institute of Medicine's Questions on Postmarket Surveillance of Pediatric Medical Devices  (pdf)
Accompanying Appendices Submitted with AdvaMed Comments  (pdf)

 

Reuse

06/06/07 Recall Notices for Reprocessed Single Patient Use Devices (pdf)
11/10/05 Comments on FDA Draft Guidance for Industry and FDA staff: Compliance with MDUFMA Act of 2002, as amendedProminent and Conspicuous Mark of Manufacturers on Single Use Devices (pdf)
02/25/05 AdvaMed Comments on High NSE Rate and Need to Review Validation Data for All Reprocessed Single-Use Devices (pdf)

 

MDR/ Adverse Events

08/22/05 AdvaMed submitted comments to FDA regarding their draft guidance on Emergency Use Authorization (pdf)
08/22/05 AdvaMed submitted comments on whether FDA's MedWatch forms should be amended to improve the utilization of available space and to allow for information on non-device products to share data fields with items D-10 and D-11 (pdf)
05/03/05 "AdvaMed files comments on FDA proposed changes to MedWatch Forms" for 2004N-0535, and "AdvaMed files comments on FDA proposed changes to Medical Device Reporting regulation" for 2004N-0527  (pdf)

 

Industry Guidance

12/03/08 AdvaMed Issues Revised Draft Guidance for Pulse Generator and Lead Product Performance Reports (pdf)
07/24/08 AdvaMed Comments on the Draft Guidance for Industry on Coronary Drug-Eluting Stents -Nonclinical and Clinical Studies (pdf)
06/25/08 AdvaMed Comments regarding the Draft Guidance for Industry on Coronary Drug-Eluting Stents-NonClinical and Clinical Studies Companion Document (pdf)
04/29/08 Coronary Drug-Eluting Stents -Clinical and Non-clinical Studies -AdvaMed-FDA Cosponsored workshop --Speaker Presentations (pdf)
01/16/08 (Members Only)AdvaMed Comments on Pediatric PMA Tracking Recommendations (pdf)
01/30/07 Uniform Reporting of Clinical Performance of Pulse Generators  (pdf)
03/16/06 Proposal Requirements for Uniform Reporting of Clinical Performance of Pulse Generators (pdf)

 

Quality Systems

05/15/03

Points to Consider When Preparing for an FDA Inspection Under the QSIT Design Controls Subsystem (pdf)

06/05/01

Points to Consider when Preparing for an FDA Inspection under the QSIT Corrective & Preventive Actions Subsystem (pdf)

10/6/99

Points to Consider when Preparing for an FDA Inspection Under the QSIT Management Controls Subsystem (pdf)