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Premarket

Pre-market approval (PMA)

11/18/08   Health Canada Extends Date for IEC 60601 (pdf)
11/14/05 AdvaMed's comments to FDA on Draft Guidance on Procedures for Handling Post-Approval Studies Imposed by PMA Order (pdf)
05/02/05 AdvaMed Comments Submitted to FDA Regarding Evaluation of the Status of Condition of Approval Studies (pdf)
01/07/05 AdvaMed's Comments to FDA on Agency's Proposed Performance Goals for Premarket Modular Review (pdf)

 

Barcoding/Auto-ID

09/01/04 AdvaMed Auto-ID Survey Report (pdf)

 

510(k)

08/19/08 The 510(k) Process: The Key to Effective Device Regulation (pdf)  White Paper
03/29/00 FDA Issues New Guidance for the Use of Standards in 510(k)s

 

Clinical Trials

03/13/08 AdvaMed's testimony before the Institute of Medicine's (IoM) Committee on Conflict of Interest in Medical Research, Education and Practice  (pdf)
01/31/08   (Members Only)AdvaMed Comments on Title VIII, Clinical Trial Databases of the FDA Amendments Act of 2007 (pdf)
07/10/07   AdvaMed Comments on Quality in Clinical Investigations  (pdf)
04/30/07 AdvaMed Comments on the GHTF SG5 Working Draft:  "Clinical Investigations"
01/12/06 AdvaMed Comments on HHS Office of Human Research Protection Draft "Guidance on Reporting and Reviewing Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others" (pdf)
12/08/05 AdvaMed Letter to World Health Organization (WHO) Urging Device Representation on Clinical Trial Registry Project (pdf)
09/20/05 (Members Only) AdvaMed Letter to the Institute of Medicine Requesting Clarification on Clinical Trials Registry Project (pdf)
08/30/05 (Members Only) Institute of Medicine Agrees to Explicitly Exclude Devices from its Clinical Trials Registry Project  (pdf)
08/09/05 (Members Only) AdvaMed Letter to the Institute of Medicine Requesting Clarification on Clinical Trials Registry Project (pdf)
04/21/05 AdvaMed comments to FDA regarding reporting of Adverse Events to Institutional Review Boards (pdf)

 

Product Development

02/07/03 AdvaMed comments submitted to Office of the Inspector General of HHS on exceptions under section 1128A (a)(5) of the Social Security Act, regarding inducements related to clinical trials (pdf)