# Investigational Device Exemptions; Treatment Use
> **Food and Drug Administration** · Final rule. · Published 1997-09-18 · Effective 1998-01-16 · 62 FR 48940
## Document
- **Document number:** 97-24735
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 62 FR 48940
- **CFR reference:** 21 CFR 812
- **Publication date:** 1997-09-18
- **Effective date:** 1998-01-16
- **HHS docket:** Docket No. 96N-0299
## Abstract

The Food and Drug Administration (FDA) is establishing procedures to allow for the treatment use of investigational devices. These procedures are intended to facilitate the availability of promising new therapeutic and diagnostic devices to desperately ill patients as early in the device development process as possible, i.e., before general marketing begins, and to obtain additional data on the device's safety and effectiveness. These procedures apply to patients with serious or immediately life-threatening diseases or conditions for which no comparable or satisfactory alternative device, drug, or other therapy exists.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1997/09/18/97-24735/investigational-device-exemptions-treatment-use)
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