# Medical Devices; Immunology and Microbiology Devices; Classification of Cystic Fibrosis Transmembrane Conductance Regulator Gene Mutation Detection System
> **Food and Drug Administration** · Final rule. · Published 2005-10-26 · Effective 2005-11-25 · 70 FR 61736
## Document
- **Document number:** 05-21348
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 70 FR 61736
- **CFR reference:** 21 CFR 866
- **Publication date:** 2005-10-26
- **Effective date:** 2005-11-25
- **HHS docket:** Docket No. 2005P-0397
## Abstract

The Food and Drug Administration (FDA) is classifying the cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection systems into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: CFTR Gene Mutation Detection Systems." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for the device.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2005/10/26/05-21348/medical-devices-immunology-and-microbiology-devices-classification-of-cystic-fibrosis-transmembrane)
---
*AI Analytics · CC0 1.0*