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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