# Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products
> **Food and Drug Administration** · Final rule. · Published 2019-04-02 · Effective 2019-05-02 · 84 FR 12505
## Document
- **Document number:** 2019-06187
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 84 FR 12505
- **CFR reference:** 21 CFR 600
- **Publication date:** 2019-04-02
- **Effective date:** 2019-05-02
- **HHS docket:** Docket No. FDA-2017-N-7007
## Abstract

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule amending the general biologics regulations relating to time of inspection requirements and also removing duties of inspector requirements. FDA is taking this action to remove outdated requirements and accommodate new approaches, such as a risk-based inspection frequency for drug and device establishments, thereby providing flexibility without diminishing public health protections. This action is part of FDA's implementation of Executive Orders (E.O.s) 13771 and 13777. Under these E.O.s, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction, while allowing the Agency to achieve our public health mission and fulfill statutory obligations.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2019/04/02/2019-06187/removal-of-certain-time-of-inspection-and-duties-of-inspector-regulations-for-biological-products)
---
*AI Analytics · CC0 1.0*