# 21 CFR § 860.10: Implants and life-supporting or life-sustaining devices

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-860.10

## Section

- **Citation:** 21 CFR § 860.10
- **Heading:** Implants and life-supporting or life-sustaining devices
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES > PART 860—MEDICAL DEVICE CLASSIFICATION PROCEDURES > Subpart A—General

## Text

(a) A classification panel will recommend classification into class III of any implant or life-supporting or life-sustaining device unless the panel determines that such classification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. If the panel recommends classification or reclassification of such a device into a class other than class III, it shall set forth in its recommendation the reasons for so doing and an identification of the risks to health, if any, presented by the device. In the case of such a device being recommended for classification or reclassification into class II, the panel shall describe the special controls that, in addition to general controls, the panel believes are necessary to provide reasonable assurance of safety and effectiveness of the device and how such controls provide such assurance.
(b) The Commissioner will classify an implant or life-supporting or life-sustaining device into class III unless the Commissioner determines that such classification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. If the Commissioner proposes to classify or reclassify such a device into a class other than class III, the regulation or order effecting such classification or reclassification will be accompanied by a full statement of the reasons for so doing. A statement of the reasons for not classifying or retaining the device in class III may be in the form of concurrence with the reasons for the recommendation of the classification panel, together with supporting documentation and data satisfying the requirements of § 860.7 and an identification of the risks to health, if any, presented by the device. In the case of such a device being classified or reclassified into class II, the Commissioner shall describe the special controls that, in addition to general controls, the panel believes are necessary to provide reasonable assurance of safety and effectiveness of the device and how such controls provide such assurance.
[83 FR 64455, Dec. 17, 2018]

## Nearby sections

- [21 CFR § 860.1 § 860.1 Scope.](https://www.frixlaw.com/law-library/statutes/ecfr-21-860.1.md)
- [21 CFR § 860.3 § 860.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-860.3.md)
- [21 CFR § 860.5 § 860.5 Confidentiality and use of data and information submitted in connection with classification and reclassification.](https://www.frixlaw.com/law-library/statutes/ecfr-21-860.5.md)
- [21 CFR § 860.7 § 860.7 Determination of safety and effectiveness.](https://www.frixlaw.com/law-library/statutes/ecfr-21-860.7.md)
- [21 CFR § 860.10 § 860.10 Implants and life-supporting or life-sustaining devices.](https://www.frixlaw.com/law-library/statutes/ecfr-21-860.10.md)
- [21 CFR § 860.15 § 860.15 Exemptions from sections 510, 519, and 520(f) of the Federal Food, Drug, and Cosmetic Act.](https://www.frixlaw.com/law-library/statutes/ecfr-21-860.15.md)
- [21 CFR § 860.84 § 860.84 Classification procedures for “preamendments devices.”](https://www.frixlaw.com/law-library/statutes/ecfr-21-860.84.md)
- [21 CFR § 860.90 § 860.90 Consultation with panels.](https://www.frixlaw.com/law-library/statutes/ecfr-21-860.90.md)
- [21 CFR § 860.120 § 860.120 General.](https://www.frixlaw.com/law-library/statutes/ecfr-21-860.120.md)
- [21 CFR § 860.123 § 860.123 Reclassification petition: Content and form.](https://www.frixlaw.com/law-library/statutes/ecfr-21-860.123.md)
- [21 CFR § 860.125 § 860.125 Consultation with panels.](https://www.frixlaw.com/law-library/statutes/ecfr-21-860.125.md)
- [21 CFR § 860.130 § 860.130 General procedures under section 513(e) of the Federal Food, Drug, and Cosmetic Act.](https://www.frixlaw.com/law-library/statutes/ecfr-21-860.130.md)
- [21 CFR § 860.132 § 860.132 Procedures when the Commissioner initiates a performance standard or premarket approval proceeding under section 514(b) or 515(b) of the Federal Food, Drug, and Cosmetic Act.](https://www.frixlaw.com/law-library/statutes/ecfr-21-860.132.md)
- [21 CFR § 860.133 § 860.133 Procedures when the Commissioner initiates a proceeding to require premarket approval under section 515(b) of the Federal Food, Drug, and Cosmetic Act.](https://www.frixlaw.com/law-library/statutes/ecfr-21-860.133.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-860.10. Check the current official text before relying on it. Not legal advice.