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21 C.F.R. § 860.132   Procedures when the Commissioner initiates a performance standard or premarket approval proceeding under section 514(b) or 515(b) of the act.

Title 21: Food and Drugs
PART 860—MEDICAL DEVICE CLASSIFICATION PROCEDURES
Subpart C—Reclassification

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§ 860.132   Procedures when the Commissioner initiates a performance standard or premarket approval proceeding under section 514(b) or 515(b) of the act.

(a) Sections 514(b) and 515(b) of the act require the Commissioner to provide, by notice in the Federal Register, an opportunity for interested parties to request a change in the classification of a device based upon new information relevant to its classification when the Commissioner initiates a proceeding either to develop a performance standard for the device if in class II, or to promulgate a regulation requiring premarket approval for the device if in class III. In either case, if the Commissioner agrees that the new information warrants a change in classification, the Commissioner will publish in the Federal Register notice of the Commissioner's intent to initiate a proceeding under section 513(e) of the act and §860.130 to effect such a change.

(b) The procedures for effecting a change in classification under sections 514(b) and 515(b) of the act are as follows:

(1) Within 15 days after publication of the Commissioner's notice referred to in paragraph (a) of this section, an interested person files a petition for reclassification in accordance with §860.123.

(2) The Commissioner consults with the appropriate classification panel with regard to the petition in accordance with §860.125.

(3) Within 60 days after publication of the notice referred to in paragraph (a) of this section, the Commissioner, by order published in the Federal Register, either denies the petition or gives notice of his intent to initiate a change in classification in accordance with §860.130.