Adverse Event Reporting for Combination Products Bradley Merrill Thompson Leighton Hansel Colleen Hittle

1. Adverse Event Reporting for Combination ProductsBradley Merrill ThompsonLeighton HanselColleen Hittle

2. FDA’s concept paper • General principles • For most combination products, appropriate AE reporting may be achieved by following the regulatory provisions associated with the type of marketing application used for approval. • But this does leave gaps. • For example, following the MDR for a drug/device combination would leave out some important drug type information.

3. Differences in AE reporting schemes • Device malfunction reporting • Five day MDR reporting • Drug and biological product “alert” reporting • Blood related deaths

4. FDA’s conceptual alternatives • Combination products approved under one marketing application. • For these, FDA could simply require that the manufacturer follow the rules associated with the marketing application. • Combination products approved under separate marketing applications. • If both applications filed by the same manufacturer, where the most likely part associated with the incident can be identified, the manufacturer would follow the rules associated with that part. • If not, the manufacturer would follow the rules associated with the lead review Center. • If the two applications are filed by separate manufacturers, each manufacturer would file according to the marketing application used for the part they made. • FDA is unsure of what to do when a manufacturer believes that the other manufacturer has the responsibility.

5. CPC Comments • Let’s remember that combination products come in three flavors: • Cross labeled • Kits • Single entity • CPC in its comment letter put together a table showing how interim and unified safety reporting systems could be accomplished.

6. Conceptual alternatives

7. Questions or comments? Questions or comments?