# 21 CFR § 860.1: Scope

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-860.1

## Section

- **Citation:** 21 CFR § 860.1
- **Heading:** Scope
- **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) This part implements sections 513, 514(b), 515(b), and 520(l) of the Federal Food, Drug, and Cosmetic Act with respect to the classification and reclassification of devices intended for human use.
(b) This part prescribes the criteria and procedures to be used by advisory committees, including classification panels, where applicable, in making their recommendations, and by the Commissioner in making the Commissioner's determinations regarding the class of regulatory control (class I, class II, or class III) appropriate for particular devices. Supplementing the general Food and Drug Administration procedures governing advisory committees (part 14 of this chapter), this part also provides procedures for manufacturers, importers, and other interested persons to participate in proceedings to classify and reclassify devices. This part also describes the type of data required for determination of the safety and effectiveness of a device, and the circumstances under which information submitted to advisory committees, including classification panels, or to the Commissioner in connection with classification and reclassification proceedings, will be available to the public.
[43 FR 32993, July 28, 1978, as amended at 86 FR 54846, Oct. 5, 2021]

## 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-21-860.1. Check the current official text before relying on it. Not legal advice.