Advisory
Committees
Orthopaedic and Rehabilitation Devices Panel
of the
Medical Devices Advisory Committe
June 2, 2006
R.S. Medical Bone Reclassification Petition for the Non-invasive Growth Stimulator
Briefing Information
Tab A - FDA Regulatory Information
Reclassification Overview [pdf]
Device Classification and Reclassification, Marjorie Shulman [pdf]
FDA General Device Classification Questionnaire [pdf]
Supplemental Data Sheet [pdf]
The Least Burdensom Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for the FDA and Industry, October 4, 2002 [pdf]
Tab B - RS Reclassification Petition [pdf]
Tab C - RS Medical Amendment [pdf]
Tab D - FDA Docket 2005P-0121
Docket 2005P-0121 for the RS Medical Petition to
Reclassify the Non-invasive Bone Growth Stimulator [htm]
[Second Mailing] FDA Docket 2005P-0121/CCP; Response
to Comments on RS Medical's Petition to Reclassify the Non-invasive
Bone Growth Stimulator (pdf)
Summary of submissions to Docket Number 2005P-0121 [pdf]
Docket Overview [pdf]
Tab E - FDA Executive Review [pdf]
Tab F - FDA Questions [pdf]
Page updated:
June 1, 2006
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