# 21 CFR § 860.123: Reclassification petition: Content and form > Federal · Regulations · In force URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-860.123 ## Section - **Citation:** 21 CFR § 860.123 - **Heading:** Reclassification petition: Content and form - **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 C—Reclassification ## Text (a) Unless otherwise provided in writing by the Commissioner, any petition for reclassification of a device, regardless of the section of the Federal Food, Drug, and Cosmetic Act under which it is filed, shall include the following: (1) A specification of the type of device for which reclassification is requested; (2) A statement of the action requested by the petitioner, e.g., “It is requested that _ device(s) be reclassified from class III to a class II”; (3) A statement of the basis for disagreement with the present classification status of the device; (4) A full statement of the reasons, together with supporting data satisfying the requirements of § 860.7, why the device should not be classified into its present classification and how the proposed classification will provide reasonable assurance of the safety and effectiveness of the device; (5) Representative data and information known by the petitioner that are unfavorable to the petitioner's position; (6) If the petition is based upon new information under section 513(e), 514(b), or 515(b) of the Federal Food, Drug, and Cosmetic Act, a summary of the new information; (7) Copies of source documents from which new information used to support the petition has been obtained (attached as appendices to the petition); and (8) A financial certification or disclosure statement or both as required by part 54 of this chapter. (b) Each petition submitted pursuant to this section shall be: (1) For devices regulated by the Center for Devices and Radiological Health, addressed to the Food and Drug Administration, Center for Devices and Radiological Health, Office of Policy Staff, 10903 New Hampshire Ave., Bldg. 66, Rm. 5445, Silver Spring, MD 20993-0002; for devices regulated by the Center for Biologics Evaluation and Research, addressed to the Food and Drug Administration, Center for Biologics Evaluation and Research, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002; for devices regulated by the Center for Drug Evaluation and Research, addressed to the Food and Drug Administration, Center for Drug Evaluation and Research, Central Document Control Room, 5901-B Ammendale Rd., Beltsville, MD 20705-1266, as applicable. (2) Marked clearly with the section of the Federal Food, Drug, and Cosmetic Act under which the petition is being submitted, i.e., “513(e),” “513(f)(3),” “514(b),” “515(b),” or “520(l) Petition”; (3) Bound in a volume or volumes, where necessary; and (4) Submitted in an original and two copies. [43 FR 32993, July 28, 1978, as amended at 49 FR 14505, Apr. 12, 1984; 53 FR 11253, Apr. 6, 1988; 55 FR 11169, Mar. 27, 1990; 63 FR 5254, Feb. 2, 1998; 65 FR 17137, Mar. 31, 2000; 73 FR 49942, Aug. 25, 2008; 75 FR 20916, Apr. 22, 2010; 79 FR 77388, Dec. 24, 2014; 82 FR 39535, Aug. 21, 2017; 83 FR 64456, Dec. 17, 2018; 85 FR 18443, Apr. 2, 2020] ## 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) --- Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-860.123. Check the current official text before relying on it. Not legal advice.