Six New SDTM Domains for Medical Devices

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Setting the Stage • Class II – moderate risk to the user • condoms, intravenous administration sets, sutures, inflatable blood pressure cuffs • Class III – severe risk to the user • implantable pacemakers, blood vessel stents, breast implants
Setting the Stage • Examples of recent devices cleared or approved by CDRH: • Bone fixation devices that include plates, screws and washers to treat fractures • BRAF V600E Mutation Test which is intended to be used in selecting melanoma patients whose tumors carry the BRAF V600E mutation <strong>for</strong> treatment with vemurafenib (zelboraf).
Page 1 and 2: Six New SDTM Domains for Medical De
Page 3 and 4: Setting the Stage • Blood screeni
Page 5: Setting the Stage • Classificatio
Page 10 and 11: Setting the Stage • Most submissi
Page 12 and 13: Setting the Stage • The Device su
Page 14 and 15: CDISC • Examples of differences (
Page 16 and 17: CDISC • Public Review of these 6
Page 18 and 19: CDISC • Two new variables will be
Page 20: CONTACT INFORMATION Carey G. Smoak

Six New SDTM Domains for Medical Devices

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