Global Medical Device Regulatory Strategy
x Regulatory Affairs Professionals Society
Table 17-13. North American and Other Critical Intelligence Resources. ..........................................................244
Table 19-1. Summary of Select Revenue-Generating Cell Therapy Products Currently on the Market .............276
Table 19-2. Definitions of Manipulations Considered Minimal (US) or Not Substantial (EU)..........................277
Table 19-3. Summary of Regulatory Routes and Documents Applicable to Stem Cell and/or
Device Products. .............................................................................................................................................278
Table 21-1. IMDRF SaMD Categories. ..............................................................................................................301
Table 21-2. IMDRF Clinical Evaluation Process.................................................................................................302
x Regulatory Affairs Professionals Society
Table 17-13. North American and Other Critical Intelligence Resources. ..........................................................244
Table 19-1. Summary of Select Revenue-Generating Cell Therapy Products Currently on the Market .............276
Table 19-2. Definitions of Manipulations Considered Minimal (US) or Not Substantial (EU)..........................277
Table 19-3. Summary of Regulatory Routes and Documents Applicable to Stem Cell and/or
Device Products. .............................................................................................................................................278
Table 21-1. IMDRF SaMD Categories. ..............................................................................................................301
Table 21-2. IMDRF Clinical Evaluation Process.................................................................................................302