§860.3. Definitions. — Inbound Citations

(b) All definitions in section 201 of the Federal Food, Drug, and Cosmetic Act shall apply to the regulation of quality management systems under this part and shall supersede the correlating terms and definitions in ISO 13485 (e.g., the definitions of device and labeling in section 201(h) and (m) of the Federal Food, Drug, and Cosmetic Act apply to this part and supersede the definitions for the correlating terms in ISO 13485 (labelling and medical device)). In addition, the following terms and definitions apply to this part and supersede the definitions for the correlating terms in ISO 13485 or ISO 9000:

Implantable medical device shall have the meaning of “implant” as defined in section 860.3 of this chapter.

Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes, but is not limited to, those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.

Organization shall have the meaning of “manufacturer” as defined in this part.

Rework means action taken on a nonconforming product so that it will fulfill the specified requirements in the medical device file (MDF) before it is released for distribution.

Safety and Performance shall have the meaning of “safety and effectiveness” in Clause 0.1 of ISO 13485. The phrase “safety and performance” does not relieve a manufacturer from any obligation to implement controls or other measures that provide reasonable assurance of safety and effectiveness.

(a) The purpose of this part is to establish an efficient, transparent, and thorough process to facilitate De Novo classification into class I or class II for devices for which there is no legally marketed device on which to base a review of substantial equivalence and which meet the definition of class I or class II as described in section 513(a)(1) of the Federal Food, Drug, and Cosmetic Act and § 860.3.

(1) The device does not meet the criteria under section 513(a)(1) of the Federal Food, Drug, and Cosmetic Act and § 860.3 for classification into class I or II;

(b) The criteria for determining the proper class for a device are set forth in § 860.3(c). The reclassification of any device within a generic type of device causes the reclassification of all devices within that generic type. Accordingly, a petition for the reclassification of a specific device will be considered a petition for reclassification of all devices within the same generic type.

(6) Within 90 days after the panel's recommendation is received (and no more than 210 days after the date the petition was filed), the Commissioner denies or approves the petition by order in the form of a letter to the petitioner. If the Commissioner approves the petition, the order will classify the device into class I or class II in accordance with the criteria set forth in § 860.3(c) and subject to the applicable requirements of § 860.10, relating to the classification of implants and life-supporting or life-sustaining devices, and § 860.15, relating to exemptions from certain requirements of the Federal Food, Drug, and Cosmetic Act.

(4) Within 180 days after the petition is filed (where the Commissioner has determined it to be adequate for review), the Commissioner, by order in the form of a letter to the petitioner, either denies the petition or classifies the device into class I or class II in accordance with the criteria set forth in § 860.3(c).

(a) This subpart sets forth the procedures for the original classification of a generic type of device that was in commercial distribution before May 28, 1976. Such a device will be classified by regulation into either class I (general controls), class II (special controls) or class III (premarket approval), depending upon the level of regulatory control required to provide reasonable assurance of the safety and effectiveness of the device (§ 860.3(c)). This subpart does not apply to a device that is classified into class III by statute under section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act because the Food and Drug Administration has determined that the device is not “substantially equivalent” to any device subject to this subpart or under section 520(l)(1) of the Federal Food, Drug, and Cosmetic Act because the device was regarded previously as a new drug. In classifying a preamendments device to which this section applies, the Food and Drug Administration will follow the procedures described in paragraphs (b) through (g) of this section.

(3) Class III or class II to class I if the Commissioner determines that the device meets the criteria set forth in § 860.3(c)(1) for a class I device.

(2) Class III or class I to class II if the Commissioner determines that the device meets the criteria set forth in § 860.3(c)(2) for a class II device; or

(1) Class I or class II to class III if the Commissioner determines that the device meets the criteria set forth in § 860.3(c)(3) for a class III device; or