# Postmarketing Safety Reporting for Combination Products
> **Food and Drug Administration** · Final rule. · Published 2016-12-20 · Effective 2017-01-19 · 81 FR 92603
## Document
- **Document number:** 2016-30485
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 81 FR 92603
- **CFR reference:** 21 CFR 4
- **Publication date:** 2016-12-20
- **Effective date:** 2017-01-19
- **HHS docket:** Docket No. FDA-2008-N-0424
## Abstract

The Food and Drug Administration (FDA or Agency) is issuing regulations to set forth postmarketing safety reporting requirements for combination products. Specifically, this final rule describes the postmarketing safety reporting requirements that apply when two or more different types of regulated medical products (drugs, devices, and/or biological products, which are referred to as "constituent parts" of a combination product) comprise a combination product and the combination product or its constituent parts have received FDA marketing authorization. The rule is intended to promote and protect the public health by setting forth the requirements for postmarketing safety reporting for these combination products, and is part of FDA's ongoing effort to ensure the consistency and appropriateness of the regulatory requirements for combination products.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2016/12/20/2016-30485/postmarketing-safety-reporting-for-combination-products)
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