OMB control number
Postmarketing Safety Reporting for Combination Products
OMB 0910-0834 · HHS/FDA.
OMB 0910-0834
For combination products for which the constituent parts receive marketing authorization under separate applications held by different entities, the Agency established a requirement, specific to these “constituent part applicants,” that they must share safety information they receive related to certain events with the other constituent part applicant(s), and maintain records of this information sharing.
The latest form for Postmarketing Safety Reporting for Combination Products expires 2023-10-31 and is listed under ICR 202008-0910-012.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 0834 ss 7-20-2020.pdf | Supporting Statement A |
 Sharing information with consitutents |
Information collection |
| Recordkeeping by device-led, drugs and biologics-led combination products; and shared records |
Information collection |
| Submitting various reports |
Information collection |
All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 202008-0910-012 | Extension without change of a currently approved collection | 2020-08-31 | Approved without change | |
| 201706-0910-021 | New collection (Request for a new OMB Control Number) | 2017-06-29 | Approved without change | |
| 200910-0910-001 | New collection (Request for a new OMB Control Number) | 2009-10-16 | Comment filed on proposed rule |
OMB Details
Submitting various reports
Federal Enterprise Architecture: Health - Consumer Health and Safety