Combination Products

Postmarketing Safety Reporting for Combination Products

This page provides resources regarding the final rule on postmarketing safety  reporting (PMSR) requirements for combination products that FDA issued on December 20, 2016 (81 FR 92603).  The rule, as codified in 21 CFR 4, Subpart B, describes how to comply with PMSR requirements for combination products that have received FDA marketing authorization.  Stakeholders with questions on PMSR requirements for combination products are encouraged to review these resources and, if you have questions, contact the Office of Combination Products at combination@fda.gov.

Regulations and Guidance

21 CFR 4, Subpart B.  Postmarketing Safety Reporting for Combination Products

Postmarketing Safety Reporting for Combination Products Draft Guidance for Industry and FDA Staff

Compliance Policy

At this time, Combination Product Applicants should submit PMSRs consistent with the requirements of the application type for the combination product (application-based PMSR requirements).  FDA does not intend to enforce the additional constituent part-based PMSR requirements (21 CFR 4.102(c) and (d), 21 CFR 4.104(b)(1) and (b)(2)) and recordkeeping requirements (21 CFR 4.105(b)) until:

  • July 31, 2019, for Combination Product Applicants using the FDA Adverse Event Reporting System (FAERS) and Electronic Medical Device Reporting System (eMDR) to report ICSRs.
  • January 31, 2020, for Combination Product Applicants using the Vaccine Adverse Event Reporting System (VAERS) to report ICSRs.

FDA is delaying enforcement of these provisions to ensure that Combination Product Applicants have sufficient time to update reporting and recordkeeping systems and procedures, including their information technology systems, to comply with the combination product PMSR requirements.  See:

Compliance Policy for Combination Product Postmarketing Safety Reporting Immediately in Effect Guidance for Industry and FDA Staff

Adverse Event Electronic Reporting Systems

The adverse event electronic reporting systems, FDA Adverse Event Reporting System (FAERS) and Electronic Medical Device Reporting System (eMDR) have been updated to address combination product reporting considerations, including allowing Combination Product Applicants to satisfy multiple reporting requirements in a single report.  For additional information, see the associated Technical Specifications:

FDA Adverse Event Reporting System (FAERS) Electronic Submissions

eMDR – Electronic Medical Device Reporting

FDA is considering similar updates to address combination products for vaccine combination product manufacturers that submit ICSRs via the Vaccine Adverse Event Reporting System (VAERS). 

FDA welcomes comments from combination product reporters.  Comments may be submitted to the docket for the Postmarketing Safety Reporting for Combination Products Draft Guidance (FDA-2008-N-0424-0022),  the Compliance Policy for Combination Product Postmarketing Safety Reporting (FDA-2008-N-0424-0025), or to the Office of Combination Products, combination@fda.gov.

Training and Outreach

Webinar on the Final Rule on Postmarketing Safety Reporting (PMSR) for Combination Products

Page Last Updated: 03/22/2018
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