International Combination Products
iv
Figure 3-3. CDER Leadership Chart....................................................................................................23
Figure 3-4. CDRH Leadership Chart...................................................................................................26
Figure 4-1. Pre-RFD Process Flow. ......................................................................................................38
Figure 6-1. Interactions of Human Factors and Usability.....................................................................61
Figure 7-1. Influence of Design Controls on the Design Process..........................................................75
Figure 8-1. CTD Triangle. ....................................................................................................................80
Figure 8-2. Inter-Center Consult Request Process Map. ......................................................................86
Figure 13-1. EMA Organization Chart. ...............................................................................................146
Tables
Table 1-1. Nine Types of Combination Products...................................................................................5
Table 2-1. Sample Questions to Inform the Regulatory Strategy. .......................................................11
Table 2-2. Regulatory Submission Strategy Document Elements. ......................................................13
Table 2-3. Regulatory Intelligence Resources.......................................................................................15
Table 3-1. Combination Products Policy Council Membership...........................................................28
Table 4-1. RFD and Pre-RFD Comparison .......................................................................................36
Table 5-1. Examples of Application-Based Mechanisms for Device-Led Combination Products .....50
Table 5-2. Examples of Application-Based Mechanisms for Drug or Biological Product-Led
Combination Products. .......................................................................................................51
Table 5-3. Submission Process for CPAM Requests............................................................................52
Table 7-1 Examples of Design Control Components. ........................................................................74
Table 8-1. Premarket Regulatory Pathways..........................................................................................78
Table 8-2. Code of Federal Regulation Link to eCTD........................................................................81
Table 10-1. Type of NDA/BLA Submission for a Change in a Device Constituent Part of a
Combination Product Approved Under an NDA/BLA. ..................................................109
Table 10-2. Type of PMA Submission for a Change in a Biological Product/Drug Constituent
Part of a Combination Product Approved Under a PMA................................................110
Table 10-3. Postapproval Modifications by Constituent Part...............................................................111
Table 11-1. Safety Reporting Requirements—Single Application.......................................................118
Table 11-2. Postmarketing Safety Reports—FDA Locations..............................................................120
Table 11-3. Timelines for Various Combination Product PMSR Requirements.................................121
Table 13-1. EU Countries and Their Dates of Entry. ..........................................................................144
iv
Figure 3-3. CDER Leadership Chart....................................................................................................23
Figure 3-4. CDRH Leadership Chart...................................................................................................26
Figure 4-1. Pre-RFD Process Flow. ......................................................................................................38
Figure 6-1. Interactions of Human Factors and Usability.....................................................................61
Figure 7-1. Influence of Design Controls on the Design Process..........................................................75
Figure 8-1. CTD Triangle. ....................................................................................................................80
Figure 8-2. Inter-Center Consult Request Process Map. ......................................................................86
Figure 13-1. EMA Organization Chart. ...............................................................................................146
Tables
Table 1-1. Nine Types of Combination Products...................................................................................5
Table 2-1. Sample Questions to Inform the Regulatory Strategy. .......................................................11
Table 2-2. Regulatory Submission Strategy Document Elements. ......................................................13
Table 2-3. Regulatory Intelligence Resources.......................................................................................15
Table 3-1. Combination Products Policy Council Membership...........................................................28
Table 4-1. RFD and Pre-RFD Comparison .......................................................................................36
Table 5-1. Examples of Application-Based Mechanisms for Device-Led Combination Products .....50
Table 5-2. Examples of Application-Based Mechanisms for Drug or Biological Product-Led
Combination Products. .......................................................................................................51
Table 5-3. Submission Process for CPAM Requests............................................................................52
Table 7-1 Examples of Design Control Components. ........................................................................74
Table 8-1. Premarket Regulatory Pathways..........................................................................................78
Table 8-2. Code of Federal Regulation Link to eCTD........................................................................81
Table 10-1. Type of NDA/BLA Submission for a Change in a Device Constituent Part of a
Combination Product Approved Under an NDA/BLA. ..................................................109
Table 10-2. Type of PMA Submission for a Change in a Biological Product/Drug Constituent
Part of a Combination Product Approved Under a PMA................................................110
Table 10-3. Postapproval Modifications by Constituent Part...............................................................111
Table 11-1. Safety Reporting Requirements—Single Application.......................................................118
Table 11-2. Postmarketing Safety Reports—FDA Locations..............................................................120
Table 11-3. Timelines for Various Combination Product PMSR Requirements.................................121
Table 13-1. EU Countries and Their Dates of Entry. ..........................................................................144