FDA 21 CFR 812: Investigational Device Exemptions
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21 CFR 812 provides procedures for the conduct of clinical investigations of medical devices. An approved investigational device exemption (IDE) permits a device that otherwise would be required to comply with a performance standard or to have pre-market approval to be shipped lawfully for the purpose of conducting investigations of that device.ﾠ
The sections most commonly cited in software related deficiencies are:
- 21 CFR 812.140(a) Investigator Records
- 21 CFR 812.150(a) Investigator Reports
| Issuing Body | FDA Regulations |
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