CFR section
21 CFR 812.140(a)(3): Records
PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS · Subpart G-Records and Reports
Key facts
| Citation | 21 CFR 812.140(a)(3) |
|---|---|
| Section | Records |
| Part | PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS |
| Subpart | Subpart G-Records and Reports |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, Drugs, General |
| Regulation text (excerpt) | (3) Records of each subject's case history and exposure to the device. Case histories include the case report forms and supporting data including, for example, signed and dated consent forms and medical records including, for example, progress notes of the physician, the individual's hospital chart(s), and the nurses' notes. Such records shall include: (i) Documents evidencing informed consent and, for any use of a device by the investigator without informed consent, any written concurrence of a… |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.