Drafts

Stay up to date and informed of new developments in FDA software regulation, enforcement actions, all the new and emerging standards activities, and gain access to a variety of training aides, document templates, and checklists.  These standards drafts are restricted to our Standards Navigators and Standards Navigator PLUS subscribers.  Items are listed newest to oldest.  If you have trouble finding an item of interest, send email to office@softwarecpr.com.  If you would like to become a Standards Navigator subscriber or our concierge level Standards Navigator PLUS subscriber, go to our Subscribe page.

Available UntilItem
TBDDGuide_63
TBD62304_Ed2_Questionaire
TBD62366-1_Amd_1_CDV
TBDAAMI_TIR102_21CFR820_13485
TBDAAMI_TIR97-CDV2_security_Post-market
TBDAAMI_TIR38-Safety_Case_Ed2_CDV-2
TBD62304_Ed2_presentation
TBD60601-1-2_AMD1_ED4
TBDAAMI TIR_75-Factors_to_Consider_CDV2
TBDAAMI_SW95-ICE_Data_Logger
TBDTIR38_Second_Edition
TBDFinal_Proposed_Text_of_HIT1000-1
TBDAugust_2018_MDS2_Revision
TBDAugust_2018_MDS2_Form