Postmarketing Safety Reporting for Combination Products

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 can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
0834 ss 7-20-2020.pdf Supporting Statement A
Sharing information with consitutents
Recordkeeping by device-led, drugs and biologics-led combination products; and shared records
Submitting various reports

All Historical Document Collections

202008-0910-012 Approved without change	Extension without change of a currently approved collection	2020-08-31
201706-0910-021 Approved without change	New collection (Request for a new OMB Control Number)	2017-06-29
200910-0910-001 Comment filed on proposed rule	New collection (Request for a new OMB Control Number)	2009-10-16

OMB Details

Submitting various reports

Federal Enterprise Architecture: Health - Consumer Health and Safety