# 21 CFR § 860.15: Exemptions from sections 510, 519, and 520(f) of the Federal Food, Drug, and Cosmetic Act

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-860.15

## Section

- **Citation:** 21 CFR § 860.15
- **Heading:** Exemptions from sections 510, 519, and 520(f) of the Federal Food, Drug, and Cosmetic Act
- **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 panel recommendation to the Commissioner that a device be classified or reclassified into class I will include a recommendation as to whether the device should be exempted from some or all of the requirements of one or more of the following sections of the Federal Food, Drug, and Cosmetic Act: Section 510 (registration, product listing, and premarket notification), section 519 (records and reports) and section 520(f) (good manufacturing practice requirements of the quality management system regulation), and, in the case of a recommendation for classification into class II, whether the device should be exempted from the premarket notification requirement under section 510.
(b) A regulation or an order classifying or reclassifying a device into class I will specify which requirements, if any, of sections 510, 519, and 520(f) of the Federal Food, Drug, and Cosmetic Act the device is to be exempted from or, in the case of a regulation or an order classifying or reclassifying a device into class II, whether the device is to be exempted from the premarket notification requirement under section 510, together with the reasons for such exemption.
(c) The Commissioner will grant exemptions under this section only if the Commissioner determines that the requirements from which the device is exempted are not necessary to provide reasonable assurance of the safety and effectiveness of the device.
[83 FR 64455, Dec. 17, 2018, as amended at 90 FR 55980, Dec. 4, 2025]

## 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-21-860.15. Check the current official text before relying on it. Not legal advice.