# Immediately in Effect Guidance for Industry; Compliance Policy for Combination Product Postmarketing Safety Reporting; Availability
> **Food and Drug Administration** · Notification of availability. · Published 2018-03-21 · 83 FR 12259
## Document
- **Document number:** 2018-05688
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 83 FR 12259
- **CFR reference:** 21 CFR 4
- **Publication date:** 2018-03-21
- **HHS docket:** Docket No. FDA-2008-N-0424
## Abstract

The Food and Drug Administration (FDA or we) is announcing the availability of an immediately in effect guidance for industry entitled "Compliance Policy for Combination Product Postmarketing Safety Reporting." This guidance describes FDA's compliance policy for combination product applicants and constituent part applicants and activities under FDA regulations that addresses combination product postmarketing safety reporting. This guidance is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2018/03/21/2018-05688/immediately-in-effect-guidance-for-industry-compliance-policy-for-combination-product-postmarketing)
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