# Investigational Device Exemptions; Intraocular Lenses
> **Food and Drug Administration** · Final rule. · Published 1997-01-29 · Effective 1997-03-31 · 62 FR 4164
## Document
- **Document number:** 97-2169
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 62 FR 4164
- **CFR reference:** 21 CFR 812
- **Publication date:** 1997-01-29
- **Effective date:** 1997-03-31
- **HHS docket:** Docket No. 91N-0292
## Abstract

The Food and Drug Administration (FDA) is issuing a final rule to remove the regulations on investigational device exemptions (IDE's) for intraocular lenses (IOL's). An IOL is an implant intended to surgically replace the natural lens of the human eye. FDA believes it is no longer necessary to maintain particularized regulations on IOL investigations because approved IOL's are now widely available and investigations of IOL's can be conducted under the investigational device regulations applicable to medical devices generally. This action is intended to eliminate confusion within the clinical research community and to provide uniformity to investigational device studies.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1997/01/29/97-2169/investigational-device-exemptions-intraocular-lenses)
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