CFR section
21 CFR 860.7(g)(1): Determination of safety and effectiveness
PART 860-MEDICAL DEVICE CLASSIFICATION PROCEDURES · Subpart A-General
Key facts
| Citation | 21 CFR 860.7(g)(1) |
|---|---|
| Section | Determination of safety and effectiveness |
| Part | PART 860-MEDICAL DEVICE CLASSIFICATION PROCEDURES |
| Subpart | Subpart A-General |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices |
| Regulation text (excerpt) | (1) It is the responsibility of each manufacturer and importer of a device to assure that adequate, valid scientific evidence exists, and to furnish such evidence to the Food and Drug Administration to provide reasonable assurance that the device is safe and effective for its intended uses and conditions of use. The failure of a manufacturer or importer of a device to present to the Food and Drug Administration adequate, valid scientific evidence showing that there is reasonable assurance of the… |
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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.